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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 91697

12 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
February 08, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Medtronic Sofamor Danek USA Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

12 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 12

Medtronic Grafton Putty: a) DBM S43101 GRAFTON 0.5CC PUTTY, REF S43101; b) DBM S43102 GRAFTON 1CC PUTTY, REF S43102; c) DBM S43103 GRAFTON 2.5CC PUTTY, REF S43103; d) DBM S43105 GRAFTON 5CC PUTTY, REF S43105; e) DBM S43110 GRAFTON 10CC PUTTY, REF S43110; f) DBM T43101 0.5CC GRAFTON PUTTY, REF T43101; g) DBM T43101INT 0.5CC GRAFTON PUTTY, REF T43101INT; h) DBM T43102 1CC GRAFTON PUTTY, REF T43102; i) DBM T43102INT 1CC GRAFTON PUTTY, REF T43102INT; j) DBM T43102JPN GRAFTON PUTTY 1CC JAR, REF T43102JPN; k) DBM T43103 2.5CC GRAFTON PUTTY, REF T43103; l) DBM T43103INT 2.5CC GRAFTON PUTTY, REF T43103INT; m) DBM T43103JPN GRAFTON PUTTY 2.5CC JAR, REF T43103JPN; n) DBM T43105 5CC GRAFTON PUTTY, REF T43105; o) DBM T43105INT 5CC GRAFTON PUTTY, REF T43105INT; p) DBM T43105JPN GRAFTON PUTTY 5CC JAR, REF T43105JPN; q) DBM T43110 10CC GRAFTON PUTTY, REF T43110; r) DBM T43110INT 10CC GRAFTON PUTTY, REF T43110INT; Demineralized Bone Matrix (DBM) product

Z-1323-2023
Recall number
Z-1323-2023
Initiated
February 08, 2023
Classification
Class II
Status
Ongoing
Quantity
186889 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach in the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.

Code information

a) DBM S43101 GRAFTON 0.5CC PUTTY, REF S43101, GTIN 00613994960900, Serial Numbers: A43107, A44312, A44898, A45026, A47094, A48070, A48239, A48726, A54374; b) DBM S43102 GRAFTON 1CC PUTTY, REF S43102, GTIN 00613994960894, Serial Numbers: A39801, A40711, A42973, A43546, A44572, A44970, A45136, A45543, A46181, A46352, A46538, A46924, A47103, A47710, A48122, A48391, A50563, A50858, A51802, A52414, A53427, A54070, A54689, A54892; c) DBM S43103 GRAFTON 2.5CC PUTTY, REF S43103, GTIN 00613994960887, Serial Numbers: A39091, A40452, A41163, A41376, A42289, A43008, A43345, A43555, A45523, A45714, A45746, A46289, A47357, A48134, A48230, A50024, A50343, A51014, A53131, A53706, A54060; d) DBM S43105 GRAFTON 5CC PUTTY, REF S43105, GTIN 00613994961136, Serial Numbers: A39669, A41187, A41545, A42539, A42923, A43450, A43481, A43500, A43516, A43853, A43932, A43934, A44475, A44665, A44733, A44805, A44986, A45039, A45175, A45282, A45457, A45552, A45556, A45919, A47043, A47390, A47714, A47833, A47885, A48125, A48540, A48816, A49460, A49472, A50596, A51281, A53513, A53897, A54184, A54492, A54615, A54771, A54892, A54982; e) DBM S43110 GRAFTON 10CC PUTTY, REF S43110, GTIN 00613994961129, Serial Numbers: A41514, A41616, A42444, A43082, A43201, A43235, A43608, A43805, A43852, A43925, A43955, A44054, A44267, A45150, A45454, A45474, A45680, A46359, A46622, A47260, A47287, A47525, A48070, A48080, A48092, A48565, A49050, A49411, A49520, A49924, A52108, A52214, A52379, A53417, A53518, A54052, A54164, A54172, A54245, A54678, A54994; f) DBM T43101 0.5CC GRAFTON PUTTY, REF T43101, GTIN 00643169123106, Serial Numbers: A38151-037, A38151-038, A38151-039, A38151-040, A38151-041, A38151-042, A38151-043, A38151-045, A38151-049, A38151-050, A38151-051, A38151-052, A38151-053, A38151-054, A38151-055, A38151-056, A38151-057, A38151-058, A38151-059, A38151-060, A38151-061, A38151-062, A38151-063, A38151-064, A38151-065, A38151-066, A38151-067, A38151-068, A38151-069, A38151-070, A38151-071, A38151-072, 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Distribution pattern

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Brunei Darussalam, Canada, Chile, Colombia, Denmark, Dominican Republic, Ecuador, Finland, Ghana, Greece, Guatemala, Hong Kong, India, Ireland, Israel, Jamaica, Japan, Jordan, Korea, Republic Of, Kuwait, Lebanon, Liechtenstein, Luxembourg, Macao, Malaysia, Mexico, Mongolia, Namibia, Netherlands, New Zealand, Norway, Oman, Panama, Paraguay, Peru, Philippines, Portugal, Puerto Rico, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Taiwan, Thailand, Trinidad And Tobago, United Arab Emirates, United Kingdom, Viet Nam.

device · product 2 of 12

Medtronic Grafton Crunch a) DBM S44105 GRAFTON 5CC CRUNCH, REF S44105; b) DBM S44115 GRAFTON 15CC CRUNCH, REF S44115; c) DBM T44105 5CC GRAFTON CRUNCH, REF T44105; d) DBM T44105INT 5CC GRAFTON CRUNCH, REF T44105INT; e) DBM T44115 15CC GRAFTON CRUNCH, REF T44115; f) DBM T44115INT 15CC GRAFTON CRUNCH, REF T44115INT; Demineralized Bone Matrix (DBM) product

Z-1324-2023
Recall number
Z-1324-2023
Initiated
February 08, 2023
Classification
Class II
Status
Ongoing
Quantity
5308 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach in the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.

Code information

a) DBM S44105 GRAFTON 5CC CRUNCH, REF S44105, GTIN 00613994961099, Serial Numbers: A41055, A41991; b) DBM S44115 GRAFTON 15CC CRUNCH, REF S44115, GTIN 00613994961082, Serial Numbers: A46383, A43751, A43940, A44572; c) DBM T44105 5CC GRAFTON CRUNCH, REF T44105, GTIN 00643169123120, Serial Numbers: A38507-041, A38507-042, A38507-043, A38507-044, A38507-045, A38507-046, A38507-047, A38507-048, A38507-049, A38507-050, A40379-096, A40379-097, A40379-098, A40379-099, A40379-100, A40379-101, A40379-102, A40379-103, A40379-104, A40379-105, A40379-106, A40379-107, A40379-108, A40379-109, A40379-110, A40379-111, A40379-112, A40379-113, A40379-114, A40379-115, A40379-116, A41167-031, A41167-032, A41167-033, A41167-036, A41167-037, A41167-038, A41167-039, A41167-040, A41167-041, A41167-042, A41167-043, A41167-044, A41167-045, A41167-046, A41167-047, A41167-048, A41167-049, A41167-050, A41167-051, A41167-052, A41167-053, A41167-054, A41167-055, A41167-056, A41167-057, A41167-058, A41167-059, 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A47087-039, A47087-040, A47087-041, A47087-042, A47087-043, A47087-044, A47087-045, A47087-046, A47087-047, A47087-049, A47087-050, A47087-051, A47087-052, A47087-053, A47087-054, A47087-055, A47087-056, A47087-057, A47087-058, A47087-059, A47129-073, A47129-074, A47129-075, A47129-076, A47129-077, A47129-078, A47129-079, A47129-080, A47129-081, A47129-082, A47129-083, A47129-084, A47129-085, A47129-086, A47129-087, A47129-088, A47129-089, A47129-090, A47129-091, A47129-092, A47129-093, A47129-094, A47129-095, A47129-096, A47129-097, A47129-098, A47129-099, A47129-100, A47129-101, A47129-102, A47129-103, A47129-104, A48098-037, A48098-038, A48098-039, A48098-040, A48098-041, A48098-042, A48098-043, A48098-044, A48098-045, A48098-046, A48098-047, A48098-048, A48145-050, A48145-051, A48145-052, A48145-053, A48145-054, A48145-055, A48145-056, A48145-057, A48145-058, A48145-059, A48145-060, A48145-061, A48145-062, A48145-063, A48145-064, A48145-065, A48145-066, A48145-067, A48145-068, A48145-069, A48145-070, A48145-071, A48145-072, A48145-073, A48145-074, A48145-075, A48145-076, A48145-077, A48145-078, A48145-079, A48145-080, A48593-138, A48593-139, A48593-140, A48593-141, A48593-142, A48593-143, A48593-144, A48593-145, A48593-146, A48593-147, A48593-148, A48593-149, A48593-150, A48593-151, A48593-152, A48593-153, A48593-154, A48593-155, A48593-156, A48593-157, A48593-158, A48593-159, A48593-160, A48593-161, A48593-162, A48593-163, A48593-164, A48991-120, A48991-121, A48991-122, A48991-123, A48991-124, A48991-125, A48991-126, A48991-127, A48991-128, A48991-129, A48991-130, A48991-131, A48991-132, A48991-133, A48991-134, A48991-135, A48991-136, A48991-137, A48991-138, A48991-139, A48991-140, A48991-141, A48991-142, A48991-143, A48991-144, A48991-145, A48991-146, A48991-147, A48991-148, A48991-149, A48991-150, A48991-151, A48991-152, A48991-153, A48991-154, A48991-155, A48991-156, A48991-157, A48991-158, A48991-159, A48991-160, A48991-161, A48991-162, A49650-046, A49650-047, A49650-048, A49650-049, A49650-050, A49650-051, A49650-052, A49650-053, A49650-054, A49650-055, A49650-056, A49650-057, A49650-058, A49650-059, A49650-060, A49650-061, A49650-062, A49650-063, A49650-064, A49650-065, A49650-066, A49650-067, A49650-068, A49650-069, A49650-070, A49650-071, A49710-104, A49710-105, A49710-106, A49710-107, A49710-108, A49710-109, A49710-110, A49710-111, A49747-113, A49747-114, A49747-115, A49747-116, A49747-117, A49747-118, A49747-119, A49747-120, A49747-121, A49747-122, A49747-123, A49747-124, A49747-125, A49747-126, A49747-127, A49747-128, A49747-129, A49747-130, A49747-131, A49747-132, A49747-133, A49747-134, A49747-135, A49747-136, A49864-050, A49864-051, A49864-052, A49864-053, A49864-054, A49864-055, A49864-056, A49864-057, A49864-058, A49864-059, A49864-060, A49864-061, A49864-062, A50081-080, A50081-081, A50081-082, A50081-083, A50081-084, A50081-085, A50081-086, A50081-087, A50081-088, A50081-089, A50081-090, A50081-091, A50081-092, A50081-093, A50081-094, A50081-095, A50081-096, A50081-097, A50081-098, A50081-099, A50081-100, A50081-101, A50580-026, A50580-027, A50580-028, A50580-029, A50580-030, A50580-031, A50580-032, A50580-033, A50580-034, A50580-035, A50580-036, A50580-037, A50580-038, A50580-039, A50580-040, A50580-041, A50580-042, A50580-043, A50580-044, A50580-045, A50580-046, A50580-047, A50844-064, A50844-065, A50844-066, A50844-067, A50844-068, A50844-069, A50844-070, A50844-071, A50844-072, A50844-073, A50844-074, A51585-064, A51585-065, A51585-066, A51585-067, A51585-068, A51585-069, A51585-070, A51585-071, A51585-072, A51585-073, A51585-074, A51585-075, A51585-076, A51585-077, A51585-078, A51585-079, A51585-080, A51585-081, A51585-082, A51585-083, A51585-084, A51585-085, A51585-086, A51585-087, A51585-088, A51585-089, A51585-090, A51585-091, A51585-092, A51585-093, A51585-094, A51585-095, A51585-096, A52421-050, A52421-051, A52421-052, A52421-053, A52421-054, A52421-055, A52421-056, A52421-057, A52421-058, A52421-059, A52421-060, A52421-061, A52421-062, A52421-063, A52421-064, A52421-065, A52421-066, A52421-067, A52421-068, A52421-069, A52421-070, A52421-071, A52421-072, A52421-073, A52421-074, A52421-075, A52421-076, A52421-077, A52421-078, A52421-079, A52421-080, A52421-081, A52421-082, A52421-083, A52421-084, A52421-085, A52421-086, A52421-087, A52421-088, A52421-089, A52421-090, A52460-181, A52460-182, A52460-183, A52460-184, A52460-185, A52460-186, A52460-187, A52460-188, A52460-189, A52460-190, A52711-031, A52711-032, A52711-033, A52711-034, A52711-035, A52711-036, A52711-037, A52711-038, A52711-039, A52711-040, A52711-041, A52711-042, A52711-043, A52711-044, A52711-045, A52711-046, A52711-047, A52711-048, A52711-049, A52711-050, A52711-051, A52711-052, A52711-053, A52711-054, A52711-055, A52711-056, A52711-057, A52711-058, A52711-059, A52711-060, A52711-061, A52711-062, A52711-063, A52711-064, A52711-065, A52711-066, A52711-067, A53585-026, A53585-027, A53585-028, A53585-029, A53585-030, A53585-031, A53585-032, A53585-033, A53585-034, A53585-035, A53585-036, A53585-037, A53585-038, A53585-039, A53585-040, A53585-041, A53585-042, A53585-043, A53585-044, A53585-045, A53585-046, A53585-047, A53585-048, A53585-049, A53585-050, A53585-051, A53585-053, A53751-053, A53751-054, A53751-055, A53751-056, A53751-057, A53751-058, A53751-059, A53751-060, A53751-061, A53751-062, A53751-063, A53751-064, A53751-065, A53751-066, A53751-067, A53751-068, A53751-069, A53751-070, A53751-071, A53751-072, A53751-073, A53751-074, A53751-075, A53751-076, A53751-077, A53751-078, A53751-079, A53751-080, A53751-081, A53756-127, A53756-128, A53756-129, A53756-130, A53756-131, A53756-132, A53756-133, A53756-134, A53756-135, A53756-136, A53756-137, A53756-138, A53756-139, A53756-140, A53756-141, A53756-142, A53756-143, A53756-144, A53756-145, A53756-146, A53756-147, A53756-148, A53756-149, A53756-150, A53756-151, A53756-152, A53756-153, A53756-154, A54021-026, A54021-027, A54021-028, A54021-029, A54021-030, A54021-031, A54021-032, A54021-033, A54021-034, A54021-035, A54021-036, A54021-037, A54021-038, A54021-039, A54021-040, A54021-041, A54021-042, A54021-043, A54021-044, A54119-097, A54119-098, A54119-099, A54119-100, A54119-101, A54119-102, A54119-103, A54119-104, A54119-105, A54119-106, A54119-107, A54119-108, A54119-109, A54464-113, A54464-114, A54464-115, A54675-026, A54675-027, A54675-028, A54675-029, A54675-030, A54675-031, A54675-032, A54675-033, A54675-034, A54675-035, A54675-036, A54675-037, A54675-038, A54675-039, A54675-040, A54675-041, A54675-042, A54675-043, A54675-044, A54675-045, A54675-046, A54675-047, A54675-048, A54675-049, A54675-050, A54675-051, A54675-052, A54675-053, A54675-054, A54675-055, A54675-056, A54675-057, A54675-058, A54675-059, A54675-060, A54675-061, A54675-062, A54675-063, A54675-064, A55091-031, A55091-032, A55091-033, A55091-034, A55091-036, A55091-037, A55091-038, A55091-039, A55091-040, A55091-041, A55091-042, A55091-043, A55091-044, A55091-045, A55091-046, A55091-047, A55091-048, A55091-049, A55091-050, A55091-051, A55091-052, A55091-053, A55091-054, A55091-055, A55091-056, A55091-058, A55091-059, A55091-060, A55091-061, A55091-062, A55091-063, A55091-064; d) DBM T44105INT 5CC GRAFTON CRUNCH, REF T44105INT, GTIN 00643169965034, Serial Numbers: A38507-051, A38507-052, A38507-053, A38507-054, A38507-055, A38507-056, A38507-057, A38507-058, A38507-059, A38507-060, A38507-061, A38507-062, A38507-063, A38507-064, A38507-065, A38507-066, A38507-067, A39972-046, A39972-047, A39972-048, A39972-049, A39972-050, A39972-051, A39972-052, A39972-053, A39972-054, A39972-055, A39972-056, A39972-057, A39972-058, A39972-059, A39972-060, A39972-061, A39972-062, A39972-063, A39972-064, A39972-065, A39972-066, A39972-067, A39972-068, A39972-069, A39972-070, A39972-071, A39972-072, A39972-073, A39972-074, A39972-075, A39972-076, A39972-077, A39972-078, A39972-079, A39972-080, A41213-031, A41213-032, A41213-033, A41213-034, A41213-035, A41213-036, A41213-037, A41213-038, A41213-039, A41213-040, A41213-041, A41213-042, A41213-043, A41213-044, A41213-045, A41213-046, A41213-047, A41213-048, A41213-049, A41213-050, A41213-051, A41213-052, A41213-053, A41213-054, A41213-055, A41516-026, A41516-027, A41516-028, A41516-029, A41516-030, A41516-031, A41516-032, A41516-033, A41516-034, A41516-035, A41516-036, A41516-037, A41516-038, A41516-039, A41516-040, A41516-041, A41516-042, A41516-043, A41516-045, A41516-047, A41516-048, A41516-049, A41516-050, A41516-052, A41516-053, A41516-056, A42221-281, A42221-282, A42221-283, A42323-034, A42323-035, A42323-036, A42323-037, A42323-038, A42323-039, A42323-040, A42323-041, A42323-042, A42323-043, A42323-044, A42323-045, A42323-046, A42323-047, A42323-048, A42323-049, A42323-050, A42323-051, A42323-052, A42323-053, A42323-054, A42323-055, A42323-056, A42323-057, A42323-058, A42323-059, A42753-152, A42753-153, A42753-154, A42753-155, A42753-156, A42753-157, A42760-066, A42760-067, A42760-068, A42760-069, A42760-071, A42760-073, A42760-075, A42760-076, A42760-077, A42760-078, A42760-081, A42760-082, A42760-084, A42760-085, A42760-086, A42760-087, A42760-088, A42760-089, A42760-090, A42760-091, A42760-092, A42760-093, A42760-094, A42934-087, A42934-088, A42934-089, A42934-090, A42984-033, A42984-034, A42984-035, A42984-036, A42984-037, A42984-038, A42984-039, A42984-040, A42984-041, A42984-042, A42984-043, A42984-044, A42984-045, A42984-046, A42984-047, A42984-048, A42984-049, A42984-050, A42984-051, A42984-052, A42984-053, A42984-054, A43103-183, A43103-184, A43103-185, A43103-186, A43103-187, A43103-188, A43103-189, A43103-190, A43103-191, A43103-192, A43103-193, A43103-194, A43103-195, A43103-196, A43103-197, A43103-198, A43103-199, A43103-200, A43103-201, A43103-202, A43103-203, A43103-204, A43103-205, A43103-206, A43103-207, A43103-208, A43103-209, A43103-210, A43344-155, A43344-156, A43344-157, A43344-158, A43344-159, A43344-160, A43344-161, A43344-163, A43344-164, A43344-165, A43344-168, A43344-169, A43344-170, A43344-171, A43344-172, A43344-173, A43546-101, A43546-102, A43546-103, A43546-104, A43546-105, A43546-106, A43546-107, A43546-108, A43546-109, A43546-110, A43546-111, A43546-112, A43546-113, A43546-114, A43546-115, A43546-116, A43571-095, A43571-096, A43571-097, A43571-098, A43571-099, A43571-100, A43571-101, A43571-102, A43571-103, A43571-104, A43571-105, A43571-106, A43571-107, A43571-108, A43571-109, A43571-110, A43571-111, A43571-112, A43571-113, A43571-114, A44852-091, A44852-092, A44852-093, A44852-094, A44852-095, A44852-096, A45084-086, A45084-087, A45084-088, A45084-089, A45084-090, A45084-091, A45084-092, A45084-093, A45084-094, A45084-095, A45084-096, A45084-097, A45084-098, A45084-099, A45084-100, A45084-101, A45084-102, A45084-103, A45084-104, A45084-105, A45084-106, A45084-107, A45084-108, A45084-109, A45084-110, A45084-111, A45084-112, A45084-113, A45084-114, A45084-115, A46628-221, A46628-222, A46628-223, A46628-224, A46628-225, A46628-226, A46628-227, A46628-228, A46628-229, A46628-230, A46628-231, A46628-232, A46628-233, A46628-234, A46628-235, A46628-236, A46628-237, A46628-238, A46628-239, A46628-240, A46628-241, A46628-242, A46628-243, A46628-244, A46628-245, A46628-246, A46628-247, A46628-248, A46628-249, A46628-250, A46628-251, A47081-045, A47081-046, A47081-047, A47081-048, A47081-049, A47081-050, A47081-051, A47081-052, A47081-053, A47081-054, A47081-055, A47081-056, A47081-057, A47081-058, A47081-059, A47081-060, A47087-060, A47087-061, A47087-062, A47087-063, A47087-064, A47087-065, A47087-066, A47087-067, A47087-068, A47087-069, A47087-070, A47087-071, A47087-072, A47087-073, A47087-074, A48098-049, A48098-050, A48098-051, A48098-052, A48098-053, A48098-054, A48098-055, A48098-056, A48098-057, A48098-058, A48098-059, A48098-060, A48098-061, A48098-062, A49710-112, A49710-113, A49710-114, A49710-115, A49710-116, A49710-117, A49710-119, A49710-120, A49710-121, A49710-122, A49710-123, A49710-124, A49710-125, A49710-126, A49710-127, A49747-137, A49747-138, A49747-139, A49747-140, A49747-141, A49747-142, A49747-143, A49747-144, A49747-145, A50082-058, A50082-059, A50082-060, A50082-061, A50082-062, A50082-063, A50082-064, A50082-065, A50082-066, A50082-067, A50082-068, A50082-069, A50082-070, A50082-071, A50082-072, A50082-073, A50082-074, A50082-075, A50082-076, A50082-077, A50082-078, A50082-079, A50082-080, A50082-081, A50082-082, A50082-083, A50082-084, A50082-085, A50082-086, A50082-087, A50082-088, A50082-089, A50968-031, A50968-032, A50968-033, A50968-034, A50968-035, A50968-036, A50968-037, A50968-038, A50968-039, A50968-040, A50968-041, A50968-042, A50968-043, A50968-044, A50968-045, A50968-046, A50968-047, A50968-048, A50968-049, A50968-050, A50968-051, A50968-052, A50968-053, A50968-054, A50968-055, A51981-026, A51981-027, A51981-028, A51981-029, A51981-030, A51981-031, A51981-032, A51981-033, A51981-034, A51981-035, A51981-036, A51981-037, A51981-038, A51981-039, A51981-040, A51981-041, A51981-042, A51981-043, A51981-044, A51981-045, A51981-046, A51981-047, A51981-048, A52460-162, A52460-163, A52460-164, A52460-165, A52460-166, A52460-167, A52460-168, A52460-169, A52460-170, A52460-171, A52460-173, A52460-180, A54119-110, A54119-111, A54119-112, A54119-113, A54119-114, A54119-115, A54119-116, A54119-117, A54119-118, A54119-119, A54119-120, A54119-121, A54464-086, A54464-087, A54464-088, A54464-089, A54464-093, A54464-094, A54464-095, A54464-103, A54464-107; e) DBM T44115 15CC GRAFTON CRUNCH, REF T44115, GTIN 00643169123113, Serial Numbers: A26631-051, A26631-052, A26631-053, A26631-054, A26631-055, A26631-056, A26631-057, A38377-125, A38377-126, A38377-127, A38377-128, A38377-129, A38377-130, A38377-131, A38377-132, A38377-133, A38471-041, A38471-042, A38471-043, A38471-044, A38471-045, A38471-046, A38471-047, A38472-047, A38472-048, A38472-049, A38472-050, A38472-051, A38472-052, A38796-048, A38796-049, A38796-050, A38796-051, A38796-052, A38796-053, A38796-054, A38796-055, A38796-056, A38796-057, A38796-058, A38796-059, A38796-060, A38796-061, A38796-062, A38796-063, A38796-064, A38796-065, A38796-066, A38796-067, A39047-108, A39047-109, A39047-110, A39047-111, A39047-112, A39047-113, A39091-085, A39091-086, A39091-087, A39091-088, A39091-089, A39091-090, A39091-091, A39091-092, A39091-093, A39091-094, A39111-182, A39111-183, A39111-184, A39111-185, A39111-186, A39111-187, A39111-188, A39111-189, A39111-190, A39111-191, A39111-192, A39111-193, A39111-194, A39111-195, A39111-196, A39202-053, A39202-054, A39202-055, A39202-056, A39202-057, A39202-058, A39202-059, A39202-060, A39202-061, A39202-062, A39202-063, A39202-064, A39202-065, A39202-066, A39202-067, A39202-068, A39202-069, A39202-070, A39202-071, A39245-046, A39245-047, A39245-048, A39245-049, A39245-050, A39245-051, A39245-052, A39245-053, A39245-054, A39245-055, A39245-056, A39283-114, A39283-115, A39283-116, A39283-117, A39283-118, A39283-119, A39413-267, A39413-268, A39413-269, A39413-270, A39413-271, A39413-272, A39413-273, A39413-274, A39413-275, A39413-276, A39413-277, A39512-026, A39512-027, A39512-028, A39512-029, A39512-030, A39512-031, A39512-032, A39512-033, A39512-034, A39512-035, A39512-036, A39512-037, A39512-038, A39512-039, A39512-040, A39512-041, A39512-042, A39512-043, A39512-044, A39512-045, A39512-046, A39512-047, A39516-092, A39516-093, A39516-094, A39516-095, A39516-096, A39520-103, A39520-104, A39520-105, A39520-106, A39520-107, A39520-108, A39520-109, A39520-110, A39520-111, A39811-170, A39811-171, A39811-172, A39811-173, A39811-174, A39811-175, A39811-176, A39811-177, A39811-178, A39811-179, A39811-180, A39866-164, A39866-165, A39866-166, A39866-167, A39866-168, A39866-169, A39866-170, A39866-171, A39866-172, A39866-173, A39867-049, A39867-050, A39867-051, A39867-052, A39867-053, A39867-054, A39867-055, A39867-056, A39867-057, A39962-052, A39962-053, A39962-054, 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Distribution pattern

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Brunei Darussalam, Canada, Chile, Colombia, Denmark, Dominican Republic, Ecuador, Finland, Ghana, Greece, Guatemala, Hong Kong, India, Ireland, Israel, Jamaica, Japan, Jordan, Korea, Republic Of, Kuwait, Lebanon, Liechtenstein, Luxembourg, Macao, Malaysia, Mexico, Mongolia, Namibia, Netherlands, New Zealand, Norway, Oman, Panama, Paraguay, Peru, Philippines, Portugal, Puerto Rico, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Taiwan, Thailand, Trinidad And Tobago, United Arab Emirates, United Kingdom, Viet Nam.

device · product 3 of 12

Medtronic Grafton Flex: a) DBM S42090 GRAFTON 1.5CM X 1.5CM FLEX, REF S42090; b) DBM T42090 1.5CMX1.5CM FLEX GRAFTON, REF T42090; c) DBM T42090INT 1.5CMX1.5CM FLEX GRAFTON, REF T42090INT; d) DBM T42100 2.5CMX10CM FLEX GRAFTON, REF T42100; e) DBM T42100AUS 2.5CMX10CM FLEX GRAFTON, REF T42100AUS; f) DBM T42100INT 2.5CMX10CM FLEX GRAFTON, REF T42100INT; g) DBM T42110 2.5CMX5CM FLEXGRAFTON, REF T42110; h) DBM T42110AUS 2.5CMX5CM FLEX GRAFTON, REF T42110AUS; i) DBM T42110INT 2.5CMX5CM FLEXGRAFTON, REF T42110INT; j) DBM T42150INT 5CM X 5CM FLEX GRAFTON, REF T42150INT; Demineralized Bone Matrix (DBM) product

Z-1325-2023
Recall number
Z-1325-2023
Initiated
February 08, 2023
Classification
Class II
Status
Ongoing
Quantity
2987 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach in the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.

Code information

a) DBM S42090 GRAFTON 1.5CM X 1.5CM FLEX, REF S42090, GTIN 00613994961006, Serial Numbers: A50360, A52104, A55429; b) DBM T42090 1.5CMX1.5CM FLEX GRAFTON, REF T42090, GTIN 00643169122994, Serial Numbers: A40174-066, A40174-067, A40174-068, A40174-069, A40174-070, A40174-071, A40174-072, A40174-073, A40174-074, A40174-075, A40174-076, A40174-077, A40174-078, A40174-079, A42594-022, A42594-023, A42594-024, A42594-025, A42594-026, A42594-027, A42594-028, A42594-029, A42594-030, A42594-031, A42594-032, A42594-033, A42594-034, A42594-035, A42594-036, A42594-037, A42890-011, A42890-012, A42890-013, A42890-014, A42890-015, A42890-016, A42890-017, A42890-018, A42890-019, A42890-020, A42890-021, A42890-022, A42890-023, A42890-024, A43119-101, A43119-102, A43119-103, A43119-104, A43119-105, A43220-011, A43220-012, A44574-011, A44574-012, A44574-013, A44574-014, A44574-015, A44574-016, A44616-011, A44616-012, A44616-013, A44616-014, A44616-015, A44616-016, A44616-017, A44616-018, A44616-019, A44616-020, A44616-021, A44616-022, A44616-023, A44616-024, A44616-025, A44616-026, A44616-027, A44616-028, A44616-029, A44616-030, A44616-031, A44616-032, A44616-033, A44616-034, A44616-035, A44704-011, A44704-012, A44704-013, A44704-014, A44704-015, A44704-016, A44704-017, A44704-018, A44704-019, A44704-020, A44704-021, A44704-022, A44704-023, A44704-024, A45275-011, A45275-012, A45275-013, A45275-014, A45275-015, A45275-016, A45275-017, A45275-018, A45275-019, A45275-020, A45275-021, A45275-022, A45275-023, A45275-024, A45275-025, A45275-026, A45275-027, A45275-028, A45275-029, A45275-030, A45275-031, A45275-032, A45275-033, A45275-034, A45275-035, A45544-011, A45544-012, A45544-013, A45544-014, A45544-015, A45544-016, A45544-017, A45544-018, A45544-019, A45544-020, A45544-021, A45544-022, A45544-023, A45544-024, A45544-025, A46162-011, A46162-012, A46162-013, A46162-014, A46162-015, A46162-016, A46162-017, A46162-018, A46162-019, A46162-020, A46162-021, A46162-022, A46162-023, A46162-024, A46537-011, A46537-012, A46537-013, A46537-014, A46537-015, A46537-016, A46537-017, A46537-018, A46537-019, A46537-020, A46537-021, A46537-022, A46537-023, A46537-024, A46537-025, A46537-026, A46711-024, A46711-025, A46711-026, A46711-027, A46711-028, A46711-029, A46711-030, A46711-031, A46711-032, A46711-033, A46711-034, A46711-035, A46711-036, A46711-037, A47573-011, A47573-012, A47573-013, A47573-014, A48312-011, A48312-012, A48312-013, A48312-014, A48312-015, A48312-016, A48312-017, A48312-018, A48312-019, A48472-011, A48472-012, A48472-013, A48472-014, A48472-015, A48472-016, A48472-017, A48472-018, A48472-019, A48472-020, A48472-021, A48472-022, A48759-011, A48759-012, A48759-013, A48759-014, A48759-015, A48759-016, A48759-017, A48759-018, A48759-019, A48759-020, A48759-021, A48759-023, A48759-024, A48759-025, A48759-026, A49927-011, A49927-012, A49927-013, A49927-014, A49927-015, A49927-016, A49927-017, A49927-018, A49927-019, A49927-020, A49927-021, A49927-022, A49927-023, A51087-011, A51087-012, A51087-013, A51087-014, A51087-015, A51087-016, A51087-017, A51087-018, A51102-054, A51102-055, A51102-056, A51102-057, A51102-058, A51102-059, A51102-060, A51102-061, A52712-082, A52712-083, A52712-084, A52712-085, A52712-086, A52712-087, A52712-088, A52712-089, A52712-090, A52712-091, A52712-092, A52712-093, A52712-094, A52712-095, A52712-096, A52712-097, A52712-098, A52712-099, A52712-100, A53148-011, A53148-012, A53148-013, A53148-014, A53148-015, A53284-026, A53284-027, A53284-028, A53284-029, A53284-030, A53284-031, A53284-032, A53284-033, A53284-034, A53284-035, A53284-036, A53284-037, A53284-038, A53284-039, A53284-040, A53284-041, A53284-042, A53284-043, A53284-044, A53284-045, A53284-046, A53770-011, A53770-012, A53770-013, A53770-014, A53770-015, A53770-016, A53770-017, A53770-018, A53770-019, A53770-020, A53770-021, A53770-022, A53770-023, A54399-043, A54399-044, A54399-045, A54399-046, A54399-047, A54399-048, A54399-049, A54399-050, A54399-051, A54399-052, A54399-053, A54399-054, A54399-055, A54399-056, A54399-057, A55095-050, A55095-051, A55095-052, A55095-053, A55095-054, A55095-055, A55095-056, A55095-057, A55095-058, A55095-059, A55095-060, A55095-061, A55095-062, A55095-063, A55095-064, A55095-065, A55095-066, A55095-067; c) DBM T42090INT 1.5CMX1.5CM FLEX GRAFTON, REF T42090INT, GTIN 00643169964877, Serial Numbers: A42232-041, A42232-042, A42232-043, A42232-044, A42232-045, A42232-046, A42232-047, A42232-048, A42232-049, A42232-050, A42232-051, A42232-052, A42232-053, A42232-054, A42232-055, A42232-056, A42232-057, A42232-058, A42232-059, A42232-060, A42232-061, A42232-062, A42232-063, A42851-038, A42851-039, A42851-040, A42851-041, A42851-042, A42851-043, A42851-044, A42851-045, A42851-046, A42851-047, A42851-048, A42851-049, A42851-050, A42851-051, A42851-052, A43708-049, A43708-050, A43708-051, A43708-052, A43708-053, A43708-054, A43708-055, A43708-056, A43708-057, A43708-058, A43708-059, A43708-060, A43708-061, A43708-062, A43708-063, A43708-064, A43708-065, A43708-066, A43708-067, A43708-068, A43708-069, A43708-070, A43708-071, A43708-072, A43708-073, A43708-074, A43708-075, A43708-076, A43708-077, A43708-078, A43708-079, A43708-080, A43708-082, A43708-083, A43708-084, A43708-085, A43708-086, A43708-087, A43708-088, A43708-089, A43708-090, A43708-092, A43708-093, A43708-094, A43708-095, A43708-096, A43708-099, A43708-101, A43708-102, A43708-103, A43708-104, A44398-011, A44398-012, A44398-013, A44398-014, A44398-015, A44398-016, A44398-017, A44398-018, A44398-019, A44398-020, A44398-021, A44398-022, A44398-023, A44398-024, A44398-025, A44398-026, A44398-027, A44398-028, A44398-029, A44398-030, A44398-031, A44398-032, A44398-033, A44398-034, A44398-035, A44704-025, A44704-026, A44704-027, A44704-028, A44704-029, A44704-030, A44704-031, A44704-032, A44704-033, A44704-034, A44704-035, A44704-036, A44704-037, A44704-038, A45772-011, A45772-012, A45772-013, A45772-014, A45772-015, A45826-011, A45826-012, A45826-013, A45826-014, A45898-023, A45898-024, A45898-025, A45898-026, A47573-029, A47832-021, A48759-039, A52104-039, A52104-040, A52104-041, A52104-042, A52104-043, A52104-044, A52104-045, A52104-047, A52104-048, A52104-049, A52104-050, A52104-051, A52104-052, A52104-053, A52104-054, A52104-055, A53050-011, A53050-012, A53050-013, A53050-014, A53050-015, A53050-016, A53050-017, A53050-018, A53050-019, A53050-020, A55429-021; d) DBM T42100 2.5CMX10CM FLEX GRAFTON, REF T42100, GTIN 00643169123007, Serial Numbers: A41864-011, A41864-012, A41864-013, A41864-014, A41864-015, A41864-016, A41864-017, A41864-018, A41864-019, A41864-020, A41864-021, A42890-025, A42890-026, A42890-027, A42890-028, A42890-029, A42890-030, A42890-031, A42890-032, A42890-033, A42890-034, A42890-035, A42890-036, A42890-037, A42890-038, A42964-021, A42964-022, A42964-023, A42964-024, A42964-025, A42964-026, A42964-027, A42964-028, A42964-029, A42972-061, A42972-062, A42972-063, A42972-064, A42972-065, A42972-066, A42972-067, A42972-068, A42972-069, A42972-070, A42972-071, A42972-072, A42972-073, A42972-074, A42972-075, A42972-076, A43119-106, A43119-107, A43119-108, A43119-109, A43119-110, A43119-111, A43119-112, A43119-113, A43119-114, A43119-115, A43119-116, A43119-117, A43119-118, A43155-016, A43155-017, A43155-018, A43155-019, A43155-020, A43155-021, A43155-022, A43155-023, A43155-024, A43155-025, A43155-026, A43281-030, A43281-031, A43281-032, A43281-033, A43281-034, A43281-035, A43281-036, A43281-037, A43281-038, A43281-039, A43281-040, A43403-011, A43403-012, A43403-013, A43403-014, A43403-015, A43403-016, A43403-017, A43403-018, A43403-019, A43403-020, A43403-021, A43403-022, A43403-023, A43403-024, A43403-025, A43708-105, A43708-106, A43708-107, A43708-108, A43708-109, A43708-110, A44100-011, A44100-012, A44100-013, A44100-014, A44100-015, A44100-016, A44100-017, A44100-018, A44100-019, A44100-020, A44100-021, A44100-022, A44100-023, A44100-024, A44100-025, A44118-011, A44118-012, A44118-013, A44118-014, A44118-015, A44118-016, A44118-017, A44118-018, A44118-019, A44118-020, A44118-021, A44118-022, A44118-023, A44118-024, A44290-011, A44290-012, A44290-013, A44290-014, A44290-015, A44290-016, A44290-017, A44290-018, A44290-019, A44290-020, A44290-021, A44290-022, A44290-023, A44290-024, A44290-025, A44290-026, A44311-011, A44311-012, A44311-013, A44311-014, A44311-015, A44311-016, A44311-017, A44311-018, A44311-019, A44311-020, A44311-021, A44311-022, A44311-023, A44311-024, A44311-025, A44372-129, A44372-130, A44372-131, A44372-132, A44372-133, A44372-134, A44372-135, A44372-136, A44372-137, A44372-138, A44372-139, A44372-140, A44372-141, A44372-142, A44372-143, A44412-060, A44412-061, A44412-062, A44412-063, A44412-064, A44412-065, A44412-066, A44412-067, A44412-068, A44412-069, A44412-070, A44412-071, A44412-072, A44412-073, A44412-074, A44655-046, A44655-047, A44655-048, A44655-049, A44655-050, A44655-051, A44655-052, A44655-053, A44655-054, A44655-055, A44655-056, A44655-057, A44655-058, A44764-011, A44764-012, A44764-013, A44764-014, A44764-015, A44764-016, A44764-017, A44764-018, A44764-019, A44764-020, A45256-011, A45256-012, A45256-013, A45256-014, A45256-015, A45256-016, A45256-017, A45256-018, A45256-019, A45256-020, A45256-021, A45256-022, A45256-023, A45256-024, A45256-025, A45281-117, A45281-118, A45281-119, A45281-120, A45281-121, A45281-122, A45281-123, A45281-124, A45281-125, A45281-126, A45281-127, A45281-128, A45281-129, A45281-130, A45281-131, A45512-011, A45512-012, A45521-011, A45521-012, A45521-013, A45521-014, A45521-015, A45521-016, A45521-017, A45521-018, A45521-019, A45521-020, A45521-021, A45521-022, A45521-023, A45521-024, A45521-025, A45521-026, A45544-026, A45544-027, A45544-028, A45544-029, A45544-030, A45544-031, A45544-032, A45544-033, A45544-034, A45544-035, A45544-036, A45544-037, A45544-038, A45544-039, A45572-033, A45572-034, A45572-035, A45572-036, A45572-037, A45572-038, A45572-039, A45572-040, A45572-041, A45572-042, A45572-043, A45572-044, A45572-045, A45572-046, A45572-047, A45579-021, A45579-022, A45579-023, A45579-024, A45579-025, A45579-026, A45579-027, A45579-028, A45579-029, A45579-030, A45579-031, A45579-032, A45579-033, A45579-034, A45579-035, A45581-036, A45581-037, A45581-038, A45581-039, A45581-040, A45581-041, A45581-042, A45581-043, A45581-044, A45581-045, A45581-046, A45581-047, A45581-048, A45581-049, A45581-050, A45581-051, A45703-011, A45703-012, A45703-013, A45703-014, A45703-015, A45703-016, A45703-017, A45703-018, A45703-019, A45703-020, A45703-021, A45703-022, A45703-023, A45703-024, A45703-025, A45703-026, A45970-011, A45970-012, A45970-013, A45970-014, A45970-015, A45970-016, A45970-017, A45970-018, A45970-019, A45970-020, A45970-021, A45970-022, A45970-023, A45970-024, A45970-025, A45970-026, A46023-031, A46023-032, A46023-033, A46023-034, A46023-035, A46023-036, A46023-037, A46023-038, A46023-039, A46023-040, A46023-041, A46023-042, A46044-058, A46044-059, A46044-060, A46044-061, A46044-062, A46044-063, A46044-064, A46044-065, A46044-066, A46044-067, A46044-068, A46044-069, A46044-070, A46044-071, A46162-025, A46162-026, A46162-027, A46162-028, A46162-029, A46162-030, A46162-031, A46162-032, A46162-033, A46162-034, A46162-035, A46162-036, A46162-037, A46162-038, A46537-027, A46537-028, A46537-029, A46537-030, A46537-031, A46537-032, A46537-033, A46537-034, A46537-035, A46537-036, A46537-037, A46537-038, A46537-039, A46537-040, A46537-041, A46537-042, A46537-043, A46537-044, A46537-045, A46537-046, A46537-047, A46537-048, A46537-049, A46537-050, A46552-011, A46552-012, A46552-013, A46552-014, A46552-015, A46552-016, A46552-017, A46552-018, A46552-019, A46552-020, A46552-021, A46552-022, A46552-023, A46552-024, A46583-011, A46583-012, A46583-013, A46583-014, A46583-015, A46583-016, A46583-017, A46583-018, A46583-019, A46583-020, A46583-021, A46711-038, A46711-039, A46711-040, A46711-041, A46711-042, A46711-043, A46711-044, A46711-045, A46711-046, A46711-047, A46711-048, A46711-049, A46711-050, A46711-051, A46711-052, A46711-053, A46711-054, A46711-055, A46711-056, A46711-057, A46711-058, A46711-059, A46849-127, A46849-129, A46849-130, A46849-131, A46849-132, A46849-133, A46849-134, A46849-135, A46849-136, A46891-042, A46891-043, A46891-044, A46891-045, A46891-046, A46991-031, A46991-032, A46991-033, A46991-034, A46991-035, A46991-036, A46991-037, A46991-038, A46991-039, A46991-040, A46991-041, A46991-042, A46991-043, A46991-044, A46991-045, A47264-011, A47264-012, A47264-013, A47264-014, A47264-015, A47264-016, A47264-017, A47264-018, A47264-019, A47264-020, A47264-021, A47264-022, A47264-023, A47264-024, A47264-025, A47264-026, A47264-027, A47264-028, A47264-029, A47264-030, A47264-031, A47264-032, A47264-033, A47264-034, A47264-035, A47264-036, A47264-037, A47264-038, A47264-039, A47264-040, A47264-041, A47293-136, A47293-137, A47293-138, A47293-139, A47293-140, A47293-141, A47293-142, A47293-143, A47293-144, A47293-145, A47293-146, A47293-147, A47293-148, A47293-149, A47293-150, A47345-011, A47345-012, A47345-013, A47345-014, A47345-015, A47345-016, A47345-017, A47345-018, A47345-019, A47345-020, A47345-021, A47345-022, A47345-023, A47345-024, A47345-025, A47345-026, A47345-027, A47345-028, A47345-029, A47345-030, A47345-031, A47345-032, A47345-033, A47345-034, A47345-035, A47345-036, A47345-037, A47345-038, A47369-011, A47369-012, A47369-013, A47369-014, A47369-015, A47369-016, A47369-017, A47369-018, A47369-019, A47369-020, A47369-021, A47369-022, A47369-023, A47369-024, A47514-024, A47514-025, A47514-026, A47514-027, A47514-028, A47514-029, A47514-030, A47514-031, A47573-015, A47573-016, A47573-017, A47573-018, A47573-019, A47573-020, A47573-021, A47573-022, A47573-023, A47573-024, A47573-025, A47573-026, A47573-027, A47573-028, A47577-036, A47577-037, A47577-038, A47577-039, A47577-040, A47577-041, A47577-042, A47577-043, A47577-044, A47577-045, A47577-046, A47577-047, A47577-048, A47577-049, A47577-050, A47577-051, A47590-029, A47590-030, A47590-031, A47590-032, A47590-033, A47590-034, A47590-035, A47590-036, A47590-037, A47590-038, A47590-039, A47590-040, A47590-041, A47590-042, A47864-017, A47864-018, A47864-019, A47864-020, A47864-021, A47864-022, A47864-023, A47864-024, A47864-025, A47864-026, A47864-027, A47864-028, A47864-029, A47864-030, A47864-031, A47864-032, A47864-033, A47864-034, A47864-035, A47864-036, A47864-037, A47864-038, A47864-039, A47864-040, A47864-041, A48052-011, A48052-012, A48052-013, A48052-014, A48052-015, A48052-016, A48052-017, A48052-018, A48052-019, A48052-020, A48052-021, A48052-022, A48052-023, A48052-024, A48154-011, A48154-012, A48154-013, A48154-014, A48154-015, A48154-016, A48154-017, A48154-018, A48154-019, A48154-020, A48154-021, A48234-011, A48234-012, A48234-013, A48234-014, A48234-016, A48234-017, A48234-018, A48234-019, A48234-020, A48234-021, A48234-022, A48234-023, A48234-024, A48472-023, A48472-024, A48472-025, A48472-026, A48472-027, A48472-028, A48472-029, A48472-030, A48472-031, A48472-032, A48472-033, A48472-034, A48556-011, A48556-012, A48556-013, A48556-014, A48556-015, A48556-016, A48556-017, A48556-018, A48556-019, A48556-020, A48556-021, A48573-077, A48573-078, A48573-079, A48573-080, A48573-081, A48573-082, A48573-083, A48573-084, A48573-085, A48573-086, A48573-087, A48573-088, A48573-089, A48573-090, A48573-091, A48573-092, A48689-011, A48689-012, A48689-013, A48689-014, A48689-015, A48689-016, A48689-017, A48689-018, A48689-019, A48689-020, A48689-021, A48689-022, A48759-027, A48759-028, A48759-029, A48759-030, A48759-031, A48759-032, A48759-033, A48759-034, A48759-035, A48759-036, A48759-037, A48759-038, A48941-011, A48941-012, A48941-013, A48941-014, A48941-015, A48941-016, A48941-017, A48941-018, A48941-019, A48941-020, A48941-021, A49861-049, A49861-050, A49861-052, A49861-053, A49861-054, A49861-055, A49861-056, A49861-057, A49861-058, A49861-059, A49861-060, A49861-061, A49861-063, A49861-064, A49861-065, A49861-066, A49861-067, A49861-068, A49861-069, A49861-070, A49861-071, A49861-072, A49861-073, A49861-074, A49930-011, A49930-012, A49930-013, A49930-014, A49930-015, A49930-016, A49930-017, A49930-018, A49930-019, A49930-020, A49930-021, A50118-011, A50118-012, A50118-013, A50118-014, A50118-015, A50118-016, A50118-017, A50118-018, A50118-019, A50118-020, A50118-021, A50118-022, A50118-023, A50118-024, A50118-025, A50281-011, A50281-012, A50281-013, A50281-014, A50281-015, A50281-016, A50281-017, A50281-018, A50281-019, A50281-020, A50281-021, A50281-022, A50281-023, A50281-024, A50281-025, A50329-011, A50329-012, A50329-013, A50329-014, A50329-015, A50360-011, A50360-012, A50360-013, A50360-014, A50360-015, A50360-018, A50360-020, A50360-021, A50360-022, A50360-023, A50360-024, A51087-019, A51087-020, A51087-021, A51087-022, A51087-023, A51087-024, A51087-025, A51087-026, A51087-027, A51087-028, A51087-029, A51087-030, A51087-031, A51087-032, A51723-011, A51723-012, A51723-013, A51723-014, A51723-015, A51723-016, A51723-017, A51723-018, A51723-019, A51723-020, A51723-021, A51723-022, A51723-023, A51723-024, A51723-025, A51978-026, A51978-027, A51978-028, A51978-029, A51978-030, A51978-031, A51978-032, A51978-033, A51978-034, A51978-035, A51978-036, A51978-037, A51992-011, A51992-012, A51992-013, A51992-014, A51992-015, A51992-016, A51992-017, A51992-018, A51992-019, A51992-020, A51992-021, A51992-022, A51992-023, A51992-024, A51992-025, A52104-056, A52104-057, A52104-058, A52104-059, A52104-060, A52104-061, A52104-062, A52104-063, A52174-011, A52174-012, A52174-013, A52174-015, A52283-052, A52283-053, A52283-054, A52283-055, A52283-056, A52283-057, A52283-058, A52283-059, A52283-060, A52283-061, A52283-062, A52283-063, A52283-064, A52283-065, A52283-066, A52510-011, A52510-012, A52510-013, A52510-014, A52510-015, A52510-016, A52510-017, A52510-018, A52510-019, A52510-020, A52510-021, A52510-022, A52510-023, A52510-024, A52510-025, A52981-041, A52981-042, A52981-043, A52981-044, A52981-045, A52981-046, A52981-047, A52981-048, A52981-050, A52981-051, A52981-052, A52981-053, A52981-054, A52981-055, A52981-056, A52981-057, A52981-058, A52981-059, A52981-060, A52981-061, A52981-062, A52981-063, A52981-064, A52981-065, A52981-066, A52981-067, A53050-021, A53050-022, A53050-023, A53050-024, A53050-025, A53050-026, A53050-027, A53050-028, A53050-029, A53050-030, A53050-031, A53050-032, A53082-011, A53082-012, A53082-013, A53082-014, A53082-015, A53082-016, A53082-017, A53082-018, A53082-019, A53082-020, A53082-021, A53082-022, A53082-023, A53082-024, A53082-025, A53133-179, A53133-180, A53133-181, A53133-182, A53133-183, A53133-184, A53133-185, A53133-186, A53133-187, A53133-188, A53133-189, A53133-190, A53133-191, A53133-192, A53148-016, A53148-017, A53148-018, A53148-019, A53148-020, A53148-021, A53148-022, A53148-023, A53148-024, A53148-025, A53148-026, A53148-027, A53148-028, A53148-029, A53181-044, A53181-045, A53181-046, A53181-047, A53181-048, A53181-049, A53181-050, A53181-051, A53181-052, A53181-053, A53181-054, A53181-055, A53181-056, A53181-057, A53181-058, A53181-059, A53284-047, A53284-048, A53284-049, A53284-050, A53284-051, A53284-052, A53284-053, A53284-054, A53284-055, A53284-056, A53284-057, A53284-058, A53284-059, A53349-084, A53349-085, A53349-086, A53349-087, A53349-088, A53349-089, A53349-090, A53349-091, A53349-092, A53349-093, A53770-024, A53770-025, A53770-026, A53770-027, A53770-028, A53770-029, A53770-030, A53813-051, A53813-052, A53813-053, A53813-054, A53813-055, A53813-056, A53813-057, A53813-058, A53813-059, A53813-060, A53813-061, A53813-062, A53813-063, A53813-064, A54163-028, A54163-029, A54293-021, A54293-022, A54293-023, A54399-031, A54399-032, A54399-033, A54399-034, A54399-035, A54399-036, A54399-037, A54399-038, A54399-039, A54399-040, A54399-041, A54399-042, A54654-011, A54654-012, A54654-013, A54654-014, A54654-015, A54654-016, A54654-017, A54654-018, A54654-019, A54654-020, A54654-021, A54654-022, A54654-023, A54654-024, A54654-025, A54654-026, A54779-011, A54779-012, A54779-013, A54779-014, A54779-015, A54779-016, A54779-017, A54779-018, A54779-019, A54779-020, A54779-021, A54779-022, A54779-023, A54783-013, A54783-014, A54783-015, A54783-016, A54783-017, A54783-018, A54783-019, A54783-020, A54783-022, A54783-025, A54809-011, A54809-012, A54809-013, A54809-014, A54809-015, A54809-016, A54809-017, A54809-018, A54809-019, A54809-020, A54809-021, A54809-022, A54809-023, A54809-024, A54809-025, A54847-011, A54847-012, A54847-013, A54960-040, A54960-041, A54960-042, A54960-043, A54960-044, A54960-045, A54960-046, A54960-047, A54960-048, A54960-049, A54960-050, A54960-051, A54960-052, A54960-053, A55095-090, A55095-091, A55095-092, A55095-093, A55095-094, A55095-095, A55095-096, A55095-097, A55095-098, A55255-011, A55255-012, A55255-013, A55255-014, A55255-015, A55255-016, A55255-017, A55255-018, A55255-019, A55255-020, A55255-021, A55255-022, A55255-023, A55255-024, A55255-025, A55255-026, A55255-027, A55255-028, A55581-022, A55581-023, A55581-024, A55610-011, A55610-012, A55610-013, A55610-014, A55610-015, A55610-016, A55610-017, A55610-018, A55610-019, A55610-020, A55610-021, A55610-022, A55610-023, A55610-024; e) DBM T42100AUS 2.5CMX10CM FLEX GRAFTON, REF T42100AUS, GTIN 00643169430969, Serial Numbers: A43708-045, A43708-046, A43708-047, A43708-048, A43995-011, A43995-012, A43995-013, A43995-014, A43995-015, A43995-016, A43995-017, A43995-018, A43995-019, A43995-020, A43995-021, A43995-022, A43995-023, A43995-024, A43995-025, A43995-026, A43995-027, A43995-028, A43995-029, A43995-030, A43995-031, A43995-032, A43995-033, A43995-034, A43995-035, A43995-036, A43995-037, A43995-038, A43995-039, A43995-040, A43995-041, A44446-066, A44446-067, A44446-068, A44446-069, A44446-070, A44446-071, A44446-072, A44446-073, A44446-074, A44446-075, A44446-076, A44446-077, A44446-078, A44446-079, A44446-080, A44446-081, A44446-082, A44446-083, A44446-084, A44446-085, A44446-086, A44446-087, A44446-088, A44446-089, A44446-090, A44446-091, A44446-092, A44446-093, A44616-036, A44616-037, A44616-038, A44616-039, A44616-040, A44616-041, A44616-042, A44616-043, A44616-044, A44616-045, A44616-046, A44616-047, A45898-027, A45898-028, A45898-029, A45898-030, A45898-031, A45898-032, A45898-033, A45898-034, A45898-035, A45898-036, A45898-037, A45898-038, A45898-039, A45898-040, A46583-022, A46583-023, A46583-024, A46583-025, A46583-026, A46583-027, A46583-028, A46583-029, A46583-030, A46583-031, A46583-032, A46583-033, A46583-034, A46583-035, A46583-036, A46583-037, A46583-038, A46583-039, A46583-040, A46583-041, A47048-011, A47048-012, A47048-013, A47048-014, A47048-015, A47048-016, A47048-017, A47048-018, A47048-019, A47048-020, A47048-021, A47048-022, A47048-023, A47048-024, A47048-025, A47345-039, A47514-032, A47514-033, A47514-034, A47514-035, A47514-036, A47514-037, A47514-038, A48154-022, A48154-023, A48154-024, A48154-025, A48154-026, A50504-045, A50504-046, A50504-047, A50504-048, A50504-049, A50504-050, A50504-051, A50705-056, A50705-057, A50705-058, A50705-059, A50705-060, A50705-061, A50705-062, A50705-063, A50705-064, A50705-065, A50705-066, A50705-067, A50705-068, A50705-069, A50705-070, A50705-071, A50705-072, A50705-073, A50705-074, A50705-075, A50705-076, A50705-077, A50705-078, A50705-079, A50705-080, A50705-081, A50705-082, A50705-083, A50705-084, A52987-011, A52987-012, A52987-013, A52987-014, A52987-015, A52987-016, A52987-017, A52987-018, A52987-019, A52987-020, A52987-021, A52987-022, A52987-023, A52987-024; f) DBM T42100INT 2.5CMX10CM FLEX GRAFTON, REF T42100INT, GTIN 00643169964884, Serial Numbers: A41864-022, A41864-025, A43220-014, A43220-015, A43220-016, A43220-017, A43220-018, A43220-019, A43220-020, A43220-021, A43220-022, A43220-023, A43220-024, A43220-025, A43220-026, A43220-027, A46552-025, A46991-046, A47264-042, A49099-011, A49099-012, A49099-013, A49099-014, A49099-015, A51978-025, A52104-064, A52104-065, A52104-066, A52981-070, A53349-081, A53349-082, A53349-083, A54391-044, A55429-033, A55429-034, A55429-035, A55429-036, A55429-037, A55429-038, A55429-039, A55429-040, A55429-041, A55429-042; g) DBM T42110 2.5CMX5CM FLEXGRAFTON, REF T42110, GTIN 00643169123014, Serial Numbers: A40174-080, A40174-081, A40174-082, A40174-083, A40174-084, A40174-085, A40174-086, A40174-087, A40174-088, A40174-089, A40174-090, A40174-091, A40174-092, A40174-093, A40174-094, A40174-095, A40174-096, A40174-097, A40174-098, A40174-099, A40174-100, A40174-101, A40174-102, A40174-103, A41995-094, A41995-095, A41995-096, A41995-097, A41995-098, A41995-099, A41995-100, A41995-101, A41995-102, A41995-103, A41995-104, A41995-105, A41995-106, A41995-107, A41995-108, A41995-109, A41995-110, A41995-111, A41995-112, A41995-113, A41995-114, A41995-115, A41995-116, A41995-117, A42328-024, A42328-025, A42328-026, A42328-027, A42328-028, A42328-029, A42328-030, A42328-031, A42328-032, A42328-033, A42328-034, A42328-035, A42328-036, A42328-037, A42328-038, A42328-039, A42328-040, A42328-042, A42328-043, A42328-044, A42328-045, A42328-046, A42328-047, A42328-048, A42328-049, A42328-050, A42328-051, A42594-038, A42594-039, A42594-040, A42594-041, A42594-042, A42594-043, A42594-044, A42594-045, A42594-046, A42594-047, A42594-048, A42594-049, A42594-050, A42594-051, A42594-052, A42594-053, A42594-054, A42594-055, A42594-056, A42594-057, A42594-058, A42594-059, A42594-060, A42594-061, A42594-062, A42594-063, A42594-064, A42851-053, A42851-054, A42851-055, A42851-056, A42851-057, A42851-059, A42851-060, A42851-061, A42851-062, A42851-064, A42851-065, A42851-066, A42851-067, A42851-068, A42851-069, A43100-051, A43100-052, A43100-053, A43100-054, A43100-055, A43100-056, A43100-057, A43100-058, A43100-059, A43100-060, A43100-061, A43100-062, A43100-063, A43100-064, A43100-065, A43100-066, A43100-067, A43100-068, A43100-069, A43100-070, A43100-071, A43100-072, A43100-073, A43100-074, A43100-075, A43100-076, A43100-077, A43100-078, A43100-079, A43100-080, A43155-027, A43155-028, A43155-029, A43155-030, A43155-031, A43155-032, A43155-033, A43155-034, A43155-035, A43947-031, A43947-032, A43947-033, A43947-034, A43947-035, A43947-036, A43947-037, A43947-038, A43947-039, A43947-040, A43947-041, A43947-042, A43947-043, A43947-044, A43947-045, A43947-046, A43947-047, A43947-048, A43947-049, A43947-050, A43947-051, A43947-052, A43947-053, A43947-054, A43947-055, A44398-036, A44398-037, A44398-038, A44398-039, A44398-040, A44398-041, A44398-042, A44398-043, A44398-044, A44398-045, A44398-046, A44398-047, A44398-048, A44398-049, A44398-050, A44398-051, A44398-052, A44398-053, A44398-054, A44398-055, A44398-056, A44398-057, A44398-058, A44574-018, A44574-020, A44574-021, A44574-022, A44574-023, A44574-024, A44574-025, A44574-026, A44574-027, A44574-028, A44574-029, A44574-030, A44574-031, A44574-032, A44574-033, A44574-034, A44574-035, A44574-036, A44574-037, A44574-038, A44574-039, A44574-040, A44574-041, A44574-043, A44574-044, A45275-036, A45275-037, A45275-038, A45275-039, A45275-040, A45275-041, A45275-042, A45275-043, A45275-044, A45275-045, A45275-046, A45275-047, A45275-048, A45275-049, A45275-050, A45275-051, A45275-052, A45275-053, A45275-054, A45275-055, A45275-056, A45275-057, A45275-058, A45275-059, A45502-011, A45502-012, A45502-013, A45502-014, A45502-015, A45502-016, A45502-017, A45502-018, A45502-019, A45502-020, A45502-021, A45502-022, A45502-023, A45502-024, A45502-025, A45502-026, A45502-027, A45502-028, A45502-029, A45502-030, A45502-031, A45502-032, A45502-033, A45502-034, A45502-035, A45502-036, A45502-037, A45502-038, A45502-039, A45502-040, A45752-011, A45752-012, A45752-013, A45752-014, A45752-015, A45752-016, A45752-017, A45752-018, A45752-019, A45752-020, A45752-021, A45752-022, A45752-023, A45752-024, A45752-025, A45752-026, A45752-027, A45752-028, A45752-029, A45752-030, A45752-031, A45752-032, A45752-033, A45752-034, A45752-035, A45752-036, A45752-037, A45752-038, A45752-039, A45772-016, A45772-017, A45772-018, A45772-019, A45772-020, A45772-021, A45772-022, A45772-023, A45772-024, A45772-025, A45772-026, A45772-027, A45772-028, A45772-029, A45772-030, A45772-031, A45772-032, A45772-033, A45772-034, A45772-035, A45772-036, A45772-040, A45772-041, A45772-042, A45772-043, A45772-044, A45826-015, A45826-016, A45826-017, A45826-019, A45826-020, A45826-021, A45826-022, A45826-023, A45826-024, A45826-026, A45826-027, A45826-028, A45826-029, A45826-030, A45826-031, A45826-032, A45826-033, A45826-034, A45826-035, A45826-036, A45826-037, A45826-038, A45826-039, A45826-040, A45826-041, A45826-042, A45826-043, A46078-015, A46078-016, A46078-017, A46078-018, A46078-019, A46078-020, A46078-021, A46078-022, A46078-023, A46078-024, A46078-025, A46078-026, A46078-027, A46078-028, A46078-029, A46078-030, A46078-031, A46078-032, A46078-033, A46078-035, A46711-060, A46711-061, A46711-062, A46711-063, A46711-064, A46711-065, A46711-066, A46711-067, A46711-068, A46711-069, A46711-070, A46711-071, A46711-072, A46711-073, A46711-074, A46711-075, A46717-031, A46717-032, A46717-033, A46717-034, A46717-035, A46717-036, A46717-037, A46717-038, A46717-039, A46717-040, A46841-031, A46841-032, A46841-033, A46841-034, A46841-035, A46841-036, A46841-037, A46841-038, A46841-039, A46841-040, A46841-041, A46841-042, A46841-043, A46841-044, A46841-045, A46841-046, A46841-047, A46841-048, A46841-049, A46841-050, A47233-026, A47233-027, A47233-028, A47233-029, A47233-030, A47233-031, A47233-032, A47233-033, A47233-034, A47233-035, A47233-036, A47233-038, A47233-039, A47233-041, A47233-042, A47233-043, A47585-011, A47585-012, A47585-013, A47585-014, A47585-015, A47585-016, A47585-017, A47585-018, A47585-019, A47585-020, A47585-021, A47585-022, A47585-023, A47585-024, A47585-025, A47585-026, A47585-027, A47585-028, A47585-029, A47585-030, A47585-031, A47585-032, A47585-033, A47585-034, A47585-035, A47585-036, A47832-028, A47832-029, A47832-030, A48202-011, A48202-012, A48202-013, A48202-014, A48202-015, A48202-016, A48202-017, A48202-018, A48202-019, A48202-021, A48202-022, A48202-023, A48202-024, A48202-025, A48202-026, A48202-027, A48202-028, A48202-029, A48202-030, A48202-031, A48202-032, A48202-033, A48202-034, A48202-035, A48202-036, A48202-037, A48202-038, A48202-039, A48202-040, A48202-041, A48202-042, A48243-016, A48243-017, A48243-018, A48243-019, A48243-020, A48243-021, A48243-022, A48243-023, A48243-024, A48243-025, A48243-026, A48243-027, A48243-028, A48243-029, A48243-030, A48243-031, A48243-032, A48243-033, A48243-034, A48243-035, A48243-036, A48243-037, A48243-038, A48243-039, A48243-040, A48243-041, A48312-024, A48312-025, A48312-026, A48312-027, A48433-011, A48433-012, A48433-013, A48433-014, A48433-015, A48433-016, A48433-017, A48433-018, A48433-019, A48433-020, A48433-021, A48433-022, A48433-023, A48433-024, A48433-025, A48433-026, A48433-027, A48433-028, A48433-029, A48433-030, A48433-031, A48433-032, A48433-033, A48433-034, A48433-035, A48433-036, A48556-022, A48556-023, A48556-024, A48556-025, A48556-026, A48556-027, A48556-028, A48556-029, A48730-031, A48730-032, A48730-033, A48730-034, A48730-035, A48730-036, A48730-037, A48730-038, A48730-039, A48730-040, A48730-041, A48730-042, A48730-043, A48730-044, A48730-045, A48730-046, A48730-047, A48730-048, A48730-049, A48730-051, A48730-052, A48730-053, A48730-054, A48730-055, A48730-056, A48730-057, A48730-058, A48730-059, A48730-060, A48730-061, A49927-026, A49927-027, A49927-028, A49927-029, A49927-030, A49927-031, A49927-032, A49927-033, A49927-034, A49927-035, A49927-036, A49927-037, A49927-038, A49927-039, A49927-040, A49927-041, A49927-042, A50183-036, A50183-037, A50183-038, A50183-039, A50183-040, A50183-041, A50183-042, A50183-043, A50183-044, A50183-045, A50183-046, A50183-047, A50183-048, A50183-049, A50183-050, A50183-051, A50183-052, A50183-053, A51102-011, A51102-012, A51102-013, A51102-014, A51102-015, A51102-016, A51102-017, A51102-018, A51102-019, A51102-020, A51102-021, A51102-022, A51102-023, A51102-024, A51102-025, A51102-026, A51102-027, A51102-028, A51102-029, A51102-030, A51102-031, A51102-032, A51102-033, A51102-034, A51102-035, A51102-036, A51102-037, A51102-038, A51410-011, A51410-012, A51410-013, A51410-014, A51410-015, A51410-016, A51410-017, A51410-018, A51410-019, A51410-020, A51410-021, A51410-022, A51410-023, A51410-024, A51410-025, A51410-026, A51410-027, A51410-028, A51410-029, A51410-030, A51410-031, A51410-032, A51410-033, A51410-034, A51410-035, A51410-036, A51410-037, A51

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Brunei Darussalam, Canada, Chile, Colombia, Denmark, Dominican Republic, Ecuador, Finland, Ghana, Greece, Guatemala, Hong Kong, India, Ireland, Israel, Jamaica, Japan, Jordan, Korea, Republic Of, Kuwait, Lebanon, Liechtenstein, Luxembourg, Macao, Malaysia, Mexico, Mongolia, Namibia, Netherlands, New Zealand, Norway, Oman, Panama, Paraguay, Peru, Philippines, Portugal, Puerto Rico, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Taiwan, Thailand, Trinidad And Tobago, United Arab Emirates, United Kingdom, Viet Nam.

device · product 4 of 12

Medtronic Grafton Orthoblend: a) DBM S44125 5CC ORTHOBLEND LARGE DEFECT, REF S44125; b) DBM S44135 15CC ORTHOBLEND LARGE DEFECT, REF S44135; c) DBM S44145 5CC ORTHOBLEND SMALL DEFECT, REF S44145; d) DBM S44150 10CC ORTHOBLEND SMALL DEFECT, REF S44150; e) DBM T44125 5CC ORTHOBLEND LARGE DEFGRAFT, REF T44125; f) DBM T44125AUS 5CC GRAFTON ORTHOBLEND LG, REF T44125AUS; g) DBM T44125INT 5CC GRAFTON ORTHOBLEND LG, REF T44125INT; h) DBM T44135 15CC ORTHOBLEND LARGE DEFGRAF, REF T44135; i) DBM T44135INT 15CC GRAFTON ORTHOBLEND LG, REF T44135INT; j) DBM T44145 5CC ORTHOBLEND SMALL DEFGRAFT, REF T44145; k) DBM T44145AUS 5CC GRAFTON ORTHOBLEND SM, REF T44145AUS; l) DBM T44145INT 5CC GRAFTON ORTHOBLEND SM, REF T44145INT; m) DBM T44150 10CC ORTHOBLEND SMALL DEFGRAF, REF T44150; n) DBM T44150AUS 10CC GRAFTON ORTHOBLEND SM, REF T44150AUS; o) DBM T44150INT 10CC GRAFTON ORTHOBLEND SM, REF T44150INT; Demineralized Bone Matrix (DBM) product

Z-1326-2023
Recall number
Z-1326-2023
Initiated
February 08, 2023
Classification
Class II
Status
Ongoing
Quantity
30541 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach in the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.

Code information

a) DBM S44125 5CC ORTHOBLEND LARGE DEFECT, REF S44125, GTIN 00613994961075, Serial Numbers: A47433, A48675; b) DBM S44135 15CC ORTHOBLEND LARGE DEFECT, REF S44135, GTIN 00613994961068, Serial Numbers: A42664; c) DBM S44145 5CC ORTHOBLEND SMALL DEFECT, REF S44145, GTIN 00613994961051, Serial Numbers: A40910, A48944, A52283; d) DBM S44150 10CC ORTHOBLEND SMALL DEFECT, REF S44150, GTIN 00613994961044, Serial Numbers: A43743; e) DBM T44125 5CC ORTHOBLEND LARGE DEFGRAFT, REF T44125, GTIN 00643169122901, Serial Numbers: A41627-069, A41627-070, A41627-071, A41627-072, A41627-073, A41627-074, A41627-076, A41627-077, A41627-078, A41627-079, A41627-080, A41627-081, A41627-083, A41627-085, A41627-087, A41627-088, A41627-089, A41627-092, A41627-093, A41627-094, A41627-095, A41755-053, A41755-054, A41755-055, A41755-056, A41755-057, A41755-058, A41755-059, A41755-060, A41755-061, A41755-062, A41755-063, A41755-064, A41755-065, A41755-066, A41755-067, A41755-068, A41755-071, A41755-072, A41755-073, A41755-074, A41755-076, A41755-077, A41755-078, A41755-079, A41755-082, A41755-083, A41755-084, A41755-085, A41755-086, A41755-087, A41755-088, A41755-089, A41755-090, A41755-091, A41755-092, A41755-093, A41755-094, A41755-095, A41755-096, A41755-097, A41755-098, A41755-099, A41755-100, A41755-101, A41755-102, A41755-103, A41755-104, A41755-105, A41755-106, A41755-107, A41755-108, A41755-109, A41755-110, A41755-111, A41755-112, A41755-113, A41755-114, A41755-115, A41755-116, A41755-117, A41755-118, A41755-119, A41755-120, A41755-121, A41755-122, A41755-123, A41755-124, A41755-125, A41755-126, A41755-127, A41755-128, A41755-129, A41755-130, A41755-131, A42328-052, A42328-053, A42328-054, A42328-055, A42328-056, A42328-057, A42328-058, A42328-059, A42328-060, A42328-061, A42328-062, A42328-063, A42328-064, A42328-065, A42328-066, A42328-067, A42328-068, A42328-069, A42328-072, A42328-074, A42328-075, A42328-076, A42328-077, A43105-035, A43105-036, A43105-037, A43105-038, A43105-039, A43105-040, A43105-041, A43105-042, A43105-043, A43105-044, A43105-045, A43105-046, A43114-053, A43114-054, A43114-055, A43114-056, A43114-057, A43114-058, A43114-059, A43114-060, A43114-061, A44317-080, A44317-081, A44317-082, A44317-083, A44317-084, A44317-085, A44317-086, A44317-087, A44317-088, A44317-089, A44317-090, A44317-091, A44317-092, A44317-093, A44317-094, A44682-067, A44682-068, A44682-069, A44682-070, A44682-071, A44682-072, A44682-073, A44682-074, A44682-075, A44682-076, A44682-077, A44682-078, A44682-079, A44682-080, A44682-081, A44682-082, A44682-083, A44682-084, A44682-085, A45053-011, A45053-012, A45053-013, A45053-014, A45053-015, A45053-016, A45053-017, A45053-018, A45053-019, A45053-020, A45053-021, A45053-022, A45053-024, A45053-025, A45053-026, A45612-034, A45612-035, A45612-036, A45612-037, A45612-038, A45612-039, A45612-040, A45612-041, A45612-042, A45612-043, A45612-044, A45612-045, A45612-046, A45612-049, A45612-050, A45612-051, A45612-052, A45612-053, A45612-054, A45612-055, A45612-056, A45612-057, A45612-058, A45612-059, A45612-060, A45612-061, A45612-062, A45612-063, A45612-064, A45612-065, A45612-066, A45612-067, A45612-068, A45612-069, A45612-070, A45612-071, A45612-072, A45612-073, A45612-074, A45612-075, A45612-076, A45612-077, A45612-078, A45612-079, A45612-080, A45612-081, A45612-082, A45612-083, A45612-084, A45612-085, A45612-086, A46728-056, A46728-057, A46728-058, A46728-059, A46728-060, A46728-061, A46728-062, A46728-063, A46728-064, A46728-065, A46728-066, A46728-067, A46728-068, A46728-069, A46728-070, A46728-071, A46728-072, A46728-073, A46728-074, A46728-075, A46728-076, A46728-077, A46728-078, A46728-079, A46728-080, A46728-081, A46728-082, A46728-083, A46728-084, A46728-085, A46728-086, A46728-087, A46728-088, A46728-089, A46728-090, A46728-091, A46728-092, A46728-093, A46728-094, A46728-095, A46728-096, A46728-097, A46728-098, A46728-099, A46728-100, A46728-101, A46728-102, A46728-103, A46728-104, A46728-105, A46728-106, A46728-107, A46728-108, A46728-109, A46728-110, A46728-111, A46728-112, A46728-113, A46728-114, A46728-115, A46728-116, A46728-117, A47648-036, A47648-037, A47648-038, A47648-039, A48717-028, A48717-029, A48717-030, A48717-031, A48717-032, A48717-033, A48717-034, A48717-035, A48717-036, A48717-037, A48717-038, A48717-039, A48717-040, A48717-041, A48717-042, A48717-043, A48717-044, A48717-045, A48717-046, A48717-047, A48717-048, A48717-049, A48717-050, A48717-051, A48717-052, A48717-053, A48717-054, A48717-055, A48717-056, A48717-057, A48717-058, A48717-059, A48717-060, A51168-011, A51168-012, A51168-013, A51168-014, A51168-015, A51168-016, A51168-017, A51168-018, A51168-019, A51168-020, A51168-021, A51168-022, A51168-023, A51168-024, A51168-025, A51168-026, A51168-027, A51168-028, A51168-029, A51168-030, A51168-031, A51168-032, A51168-033, A51168-034, A51168-035, A51168-036, A51168-037, A51168-038, A51168-039, A51168-040, A51168-041, A51168-042, A51168-043, A51168-044, A51168-045, A51168-046, A51168-047, A51168-048, A51168-049, A51168-050, A51977-214, A51977-215, A51977-216, A51977-217, A51977-218, A51977-219, A51977-220, A51977-221, A51977-222, A52744-027, A52744-028, A52744-029, A52744-030, A52744-031, A52744-032, A52744-033, A52744-034, A52744-035, A52744-036, A52744-037, A52744-038, A52744-039, A52744-040, A52744-041, A52744-042, A52744-043, A52744-044, A52744-045, A52744-046, A52744-047, A52744-048, A52744-049, A53750-193, A53750-194, A53750-195, A53750-196, A53750-198, A53750-200, A53750-209, A53750-212, A53750-213, A53750-214, A53750-235, A53750-236, A53750-237, A53750-238, A53750-239, A53750-240, A53750-243, A53750-244, A53750-245, A53750-246, A53750-247; f) DBM T44125AUS 5CC GRAFTON ORTHOBLEND LG, REF T44125AUS, GTIN 00643169431027, Serial Numbers: A42115-061, A42115-062, A42115-063, A44487-057, A44487-058, A44487-059, A44487-060, A44487-061, A44487-062, A44487-063, A44487-064, A44487-065, A44487-066, A44487-067, A44487-068, A46117-055, A46117-056, A46117-057, A46117-058, A46117-059, A47598-134, A47598-135, A47598-136, A47598-138, A47598-139, A47598-140, A47598-141, A47598-142, A47598-143, A49862-054, A49862-055; g) DBM T44125INT 5CC GRAFTON ORTHOBLEND LG, REF T44125INT, GTIN 00643169965058, Serial Numbers: A38959-090, A38959-091, A38959-092, A38959-093, A38959-094, A38959-095, A38959-096, A38959-097, A38959-098, A38959-099, A38959-100, A38959-101, A38959-102, A38959-103, A38959-104, A38959-105, A38959-106, A38959-107, A38959-108, A38959-109, A38959-110, A38959-111, A38959-112, A40657-034, A40657-035, A40657-036, A40657-037, A40657-038, A40657-039, A40657-040, A40657-041, A40657-042, A40657-043, A40657-044, A40657-045, A40657-046, A40657-047, A40657-048, A40657-049, A40657-050, A40657-051, A40657-052, A40657-053, A40657-054, A40657-055, A40657-056, A40657-057, A40657-058, A40657-059, A40657-060, A40657-061, A40657-062, A40657-063, A40657-064, A40657-065, A40657-066, A40657-067, A40657-068, A40657-069, A40657-070, A40657-071, A40657-072, A40657-073, A40657-074, A40657-075, A40657-076, A40657-077, A40657-078, A40657-079, A40657-080, A40657-081, A40657-082, A40657-083, A40657-084, A40657-085, A40657-086, A40657-087, A40657-088, A40657-089, A40657-090, A40657-091, A40657-092, A40657-093, A40657-094, A40657-095, A40657-096, A40657-097, A40657-098, A40657-099, A40657-100, A40657-101, A40657-102, A40657-103, A40657-104, A40657-105, A40657-106, A40657-107, A40657-108, A40657-109, A40657-110, A40657-111, A40657-112, A40657-113, A40657-114, A40657-115, A40657-116, A40657-117, A40657-118, A40657-119, A40657-120, A40657-121, A40657-122, A40657-123, A40657-124, A40657-125, A40657-126, A40657-127, A40657-128, A40657-129, A40657-130, A40657-134, A40657-135, A40657-138, A40657-139, A40657-140, A40657-141, A40657-142, A40657-143, A40657-144, A40657-145, A40657-146, A40657-147, A40657-148, A40657-149, A40657-150, A40657-151, A40657-152, A40657-153, A40657-154, A40657-155, A40657-156, A40657-157, A40657-158, 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Distribution pattern

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Brunei Darussalam, Canada, Chile, Colombia, Denmark, Dominican Republic, Ecuador, Finland, Ghana, Greece, Guatemala, Hong Kong, India, Ireland, Israel, Jamaica, Japan, Jordan, Korea, Republic Of, Kuwait, Lebanon, Liechtenstein, Luxembourg, Macao, Malaysia, Mexico, Mongolia, Namibia, Netherlands, New Zealand, Norway, Oman, Panama, Paraguay, Peru, Philippines, Portugal, Puerto Rico, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Taiwan, Thailand, Trinidad And Tobago, United Arab Emirates, United Kingdom, Viet Nam.

device · product 5 of 12

Medtronic Grafton Matrix: a) DBM S42200 GRAFTON 2.5CMX10CM 2EA MATRIX, REF S42200; b) DBM S42210 GRAFTON 2.5CMX5CM 2EA MATRIX, REF S42210; c) DBM T42200 2.5CMX10CM 2 EACH GRAFTON MAT, REF T42200; d) DBM T42200AUS 2.5CMX10CM 2 EA GRAFTON MX, REF T42200AUS; e) DBM T42200INT 2.5CMX10CM 2 EA GRAFTON M, REF T42200INT; f) DBM T42200JPN GRAFTON MATRIX 2.5CM X10CM, REF T42200JPN; g) DBM T42210 2.5CMX5CM 2 EACH GRAFTON MATR, REF T42210; h) DBM T42210AUS 2.5CMX5CM 2 EA GRAFTON MX, REF T42210AUS; i) DBM T42210INT 2.5CMX5CM 2 EA GRAFTON M, REF T42210INT; j) DBM T42210JPN GRAFTON MATRIX 2.5CM X 5CM, REF T42210JPN; Demineralized Bone Matrix (DBM) product

Z-1327-2023
Recall number
Z-1327-2023
Initiated
February 08, 2023
Classification
Class II
Status
Ongoing
Quantity
19057 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach in the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.

Code information

a) DBM S42200 GRAFTON 2.5CMX10CM 2EA MATRIX, REF S42200, GTIN 00613994960955, Serial Numbers: A40821, A41333, A42693, A42811, A43336, A43592, A44884, A44960; b) DBM S42210 GRAFTON 2.5CMX5CM 2EA MATRIX, REF S42210, GTIN 00613994960948, Serial Numbers: A42415, A42482, A42953, A43212, A43354, A43965, A44760, A45028, A46673, A48105, A48484, A49062, A49564, A50856, A52420, A52719, A52904, A53373; c) DBM T42200 2.5CMX10CM 2 EACH GRAFTON MAT, REF T42200, GTIN 00643169123052, Serial Numbers: A38910-046, A38910-047, A38910-048, A38910-049, A38910-050, A38910-051, A38910-052, A38910-053, A38910-054, A38910-055, A38910-056, A38910-057, A39374-061, A39374-062, A39374-063, A39374-064, A39374-065, A39374-066, A39374-067, A39374-068, A39374-069, A39374-070, A39374-071, A39374-072, A39736-021, A39736-022, A39736-023, A39736-024, A39736-025, A39736-026, A39736-027, A39736-028, A39736-029, A39736-030, A39736-031, A39736-032, A39803-051, A39803-052, A39803-053, A39803-054, A39803-055, A39803-056, 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A46250-017, A46250-018, A46250-019, A46250-020, A46250-021, A46250-022, A46263-011, A46263-012, A46263-013, A46263-014, A46263-015, A46263-016, A46263-017, A46286-011, A46286-012, A46286-013, A46286-014, A46286-016, A46286-017, A46286-018, A46310-011, A46310-012, A46310-013, A46310-014, A46310-015, A46310-016, A46310-017, A46310-018, A46310-019, A46310-020, A46310-021, A46342-011, A46342-012, A46342-013, A46342-014, A46342-015, A46342-016, A46342-017, A46358-011, A46358-016, A46358-017, A46358-018, A46387-012, A46387-013, A46387-014, A46387-015, A46397-011, A46397-012, A46397-013, A46397-014, A46397-015, A46397-016, A46397-017, A46397-018, A46397-019, A46397-020, A46397-021, A46397-022, A46397-023, A46397-024, A4640

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Brunei Darussalam, Canada, Chile, Colombia, Denmark, Dominican Republic, Ecuador, Finland, Ghana, Greece, Guatemala, Hong Kong, India, Ireland, Israel, Jamaica, Japan, Jordan, Korea, Republic Of, Kuwait, Lebanon, Liechtenstein, Luxembourg, Macao, Malaysia, Mexico, Mongolia, Namibia, Netherlands, New Zealand, Norway, Oman, Panama, Paraguay, Peru, Philippines, Portugal, Puerto Rico, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Taiwan, Thailand, Trinidad And Tobago, United Arab Emirates, United Kingdom, Viet Nam.

device · product 6 of 12

Medtronic Grafton Matrix Strips: a) DBM S42275 8MMX1CMX10CM 2EA MATRIX STRPS, REF S42275; b) DBM S42280 8MMX1CMX20CM 2EA MATRX STRPS, REF S42280; c) DBM T42275 8MMX1CMX10CM 2 EACH GRAFTON M, REF T42275; d) DBM T42275AUS 8MMX1CMX10CM 2 EA GRFTON S, REF T42275AUS; e) DBM T42275INT 8MMX1CMX10CM 2 EA GRFTON S, REF T42275INT; f) DBM T42275JPN GRAFTON MATRIX 1CM X 10CM, REF T42275JPN; g) DBM T42280 8MMX1CMX20CM 2 EACH GRAFTON M, REF T42280; h) DBM T42280AUS 8MMX1CMX20CM 2 EA GRFTON S, REF T42280AUS; i) DBM T42280INT 8MMX1CMX20CM 2 EA GRFTON S, REF T42280INT; j) DBM T42280JPN GRAFTON MATRIX 1CM X 20CM, REF T42280JPN; Demineralized Bone Matrix (DBM) product

Z-1328-2023
Recall number
Z-1328-2023
Initiated
February 08, 2023
Classification
Class II
Status
Ongoing
Quantity
23850 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach in the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.

Code information

a) DBM S42275 8MMX1CMX10CM 2EA MATRIX STRPS, REF S42275, GTIN 00613994960931, Serial Numbers: A42914, A43126, A43182, A43185, A43460, A43613, A43715, A43896, A44262, A44388, A44561, A45997, A46401, A46690, A46699, A47001, A47719, A47942, A48136, A48371, A48792, A49045, A49089, A49108, A49790, A49952, A50039, A50528, A50688, A51827, A52539, A52601, A52788, A53401, A53671, A53788, A53881, A53904, A54204, A54988, A55032, A55132; b) DBM S42280 8MMX1CMX20CM 2EA MATRX STRPS, REF S42280, GTIN 00613994960924, Serial Numbers: A42850, A43731, A44343, A44529, A44821, A45022, A45035, A46734, A47604, A47621, A47701, A47971, A48051, A48578, A49616, A51011, A52580, A52809, A54208, A54369, A54440, A54597, A55584; c) DBM T42275 8MMX1CMX10CM 2 EACH GRAFTON M, REF T42275, GTIN 00643169123076, Serial Numbers: A39563-061, A39563-062, A39563-063, A39563-064, A39563-065, A39563-066, A39563-068, A39563-070, A39563-071, A39563-072, A39563-073, A39563-074, A39563-075, A39563-076, A39563-077, A40837-011, A41106-011, A41106-012, A41106-013, A41106-014, A41106-015, A41106-016, A41106-017, A41106-018, A41106-019, A41558-011, A41558-012, A41558-013, A41558-014, A41558-015, A41558-016, A41656-011, A41656-012, A41656-013, A41656-014, A41656-015, A41656-016, A41656-017, A41656-018, A41656-019, A41656-020, A41656-021, A41656-022, A41656-023, A41656-024, A41656-025, A41656-026, A41656-027, A41656-028, A41656-029, A41656-030, A41656-031, A41656-032, A41656-033, A41656-034, A41656-035, A41656-036, A41656-037, A41656-038, A41656-039, A41656-040, A41961-011, A42020-011, A42020-012, A42020-013, A42020-014, A42020-015, A42020-016, A42020-017, A42020-018, A42020-019, A42020-020, A42020-021, A42020-022, A42020-023, A42020-024, A42020-025, A42020-026, A42020-027, A42020-028, A42085-011, A42551-011, A42551-012, A42551-013, A42551-014, A42551-015, A42551-016, A42554-011, A42554-012, A42554-013, A42554-014, A42585-011, A42585-012, A42586-011, A42586-012, A42586-013, A42586-014, A42586-015, A42586-016, 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Distribution pattern

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Brunei Darussalam, Canada, Chile, Colombia, Denmark, Dominican Republic, Ecuador, Finland, Ghana, Greece, Guatemala, Hong Kong, India, Ireland, Israel, Jamaica, Japan, Jordan, Korea, Republic Of, Kuwait, Lebanon, Liechtenstein, Luxembourg, Macao, Malaysia, Mexico, Mongolia, Namibia, Netherlands, New Zealand, Norway, Oman, Panama, Paraguay, Peru, Philippines, Portugal, Puerto Rico, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Taiwan, Thailand, Trinidad And Tobago, United Arab Emirates, United Kingdom, Viet Nam.

device · product 7 of 12

Medtronic Grafton Plus Paste a) DBM S45001 GRAFTON 1CC PASTE, REF S45001; b) DBM S45005 GRAFTON 5CC PASTE, REF S45005; c) DBM S45010 GRAFTON 10CC PASTE, REF S45010; d) DBM T45001 1CC PASTE GRAFTON PLUS, REF T45001; e) DBM T45001AUS 1CC PASTE GRAFTON PLUS, REF T45001AUS; f) DBM T45001INT 1CC PASTE GRAFTON PLUS, REF T45001INT; g) DBM T45005 5CC PASTE GRAFTON PLUS, REF T45005; h) DBM T45005INT 5CC PASTE GRAFTON PLUS, REF T45005INT; i) DBM T45010 10CC PASTE GRAFTON PLUS, REF T45010; j) DBM T45010AUS 10CC PASTE GRAFTON PLUS, REF T45010AUS; k) DBM T45010INT 10CC PASTE GRAFTON PLUS, REF T45010INT; Demineralized Bone Matrix (DBM) product

Z-1329-2023
Recall number
Z-1329-2023
Initiated
February 08, 2023
Classification
Class II
Status
Ongoing
Quantity
37721 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach in the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.

Code information

a) DBM S45001 GRAFTON 1CC PASTE, REF S45001, GTIN 00613994961037, Serial Numbers: A46006, A40308, A42539, A43901, A44220, A45597, A45671, A46339, A48873, A51546, A52593, A52757, A53414; b) DBM S45005 GRAFTON 5CC PASTE, REF S45005, GTIN 00613994961020, Serial Numbers: A40309, A43891, A45123, A45614, A46395, A46625, A46708, A48098, A48545, A48646, A48920, A49642, A50256, A51481, A51591, A52422, A52947, A53416, A53534, A53685, A53927, A54681; c) DBM S45010 GRAFTON 10CC PASTE, REF S45010, GTIN 00613994961013, Serial Numbers: A48673, A40169, A41945, A42622, A42931, A43105, A43124, A43340, A43904, A44606, A45676, A46344, A46456, A46730, A47917, A48147, A48149, A48275, A48980, A49864, A50243, A51016, A51041, A51755, A52183, A52329, A52709, A52713, A52954, A53755, A53944, A54258, A54365, A54784, A54804, A54988; d) DBM T45001 1CC PASTE GRAFTON PLUS, REF T45001, GTIN 00643169122949, Serial Numbers: A24679-156, A24679-157, A24679-158, A24679-159, A24679-160, A24679-161, A24679-162, A24679-163, 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Distribution pattern

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Brunei Darussalam, Canada, Chile, Colombia, Denmark, Dominican Republic, Ecuador, Finland, Ghana, Greece, Guatemala, Hong Kong, India, Ireland, Israel, Jamaica, Japan, Jordan, Korea, Republic Of, Kuwait, Lebanon, Liechtenstein, Luxembourg, Macao, Malaysia, Mexico, Mongolia, Namibia, Netherlands, New Zealand, Norway, Oman, Panama, Paraguay, Peru, Philippines, Portugal, Puerto Rico, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Taiwan, Thailand, Trinidad And Tobago, United Arab Emirates, United Kingdom, Viet Nam.

device · product 8 of 12

Medtronic Grafton DBF: a) PUTTY T50101 GRAFTON DBF 1CC, REF T50101; b) PUTTY T50101INT GRAFTON DBF 1CC, REF T50101INT; c) PUTTY T50103 GRAFTON DBF 3CC, REF T50103; d) PUTTY T50103INT GRAFTON DBF 3CC, REF T50103INT; e) PUTTY T50106 GRAFTON DBF 6CC, REF T50106; f) PUTTY T50106INT GRAFTON DBF 6CC, REF T50106INT; Demineralized Bone Matrix (DBM) product

Z-1330-2023
Recall number
Z-1330-2023
Initiated
February 08, 2023
Classification
Class II
Status
Ongoing
Quantity
47436 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach in the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.

Code information

a) PUTTY T50101 GRAFTON DBF 1CC, REF T50101, GTIN 00643169656017, Serial Numbers: A40005-036, A40005-037, A40005-038, A40005-039, A40005-040, A40005-041, A40005-042, A40005-043, A40005-045, A40005-046, A40005-047, A40005-048, A40005-049, A40005-051, A40005-053, A40005-054, A40005-055, A40005-056, A40005-057, A40005-058, A40005-059, A40005-060, A40005-061, A40005-062, A40005-063, A40005-064, A40005-065, A40005-066, A40005-067, A40005-068, A40005-069, A40005-070, A40005-071, A40005-072, A40005-073, A40005-074, A40005-075, A40005-076, A40005-077, A40005-078, A40005-079, A40005-080, A40005-081, A40005-082, A40005-083, A40005-084, A40005-085, A40005-086, A40005-087, A40005-088, A40005-089, A40005-090, A40005-091, A40005-092, A40005-093, A40005-094, A40005-095, A40005-096, A40005-097, A40005-098, A40005-099, A40005-100, A40005-101, A40005-102, A40304-210, A40304-211, A40304-212, A40304-213, A40304-214, A40304-215, A40304-216, A40304-217, A40304-218, A40304-219, A40304-220, A40304-221, 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Distribution pattern

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Brunei Darussalam, Canada, Chile, Colombia, Denmark, Dominican Republic, Ecuador, Finland, Ghana, Greece, Guatemala, Hong Kong, India, Ireland, Israel, Jamaica, Japan, Jordan, Korea, Republic Of, Kuwait, Lebanon, Liechtenstein, Luxembourg, Macao, Malaysia, Mexico, Mongolia, Namibia, Netherlands, New Zealand, Norway, Oman, Panama, Paraguay, Peru, Philippines, Portugal, Puerto Rico, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Taiwan, Thailand, Trinidad And Tobago, United Arab Emirates, United Kingdom, Viet Nam.

device · product 9 of 12

Medtronic Grafton DBF Inject: a) GRAFTON T50303 DBF INJECT 3CC, REF T50303; b) GRAFTON T50306 DBF INJECT 6CC, REF T50306; c) GRAFTON T50309 DBF INJECT 9CC, REF T50309; Demineralized Bone Matrix (DBM) product

Z-1331-2023
Recall number
Z-1331-2023
Initiated
February 08, 2023
Classification
Class II
Status
Ongoing
Quantity
10037 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach in the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.

Code information

a) GRAFTON T50303 DBF INJECT 3CC, REF T50303, GTIN 00763000254001, Serial Numbers: A44493-011, A44493-012, A44493-013, A44493-014, A44493-015, A44493-016, A44493-017, A44493-018, A44493-019, A44493-020, A44493-021, A44493-022, A44493-023, A44493-025, A44493-028, A44591-011, A44591-012, A44591-013, A44591-014, A44591-015, A44591-016, A44591-017, A44591-018, A44591-019, A44591-020, A44591-021, A44591-022, A44591-023, A44591-024, A44591-025, A44591-026, A44591-027, A44591-028, A44591-029, A44591-030, A44591-031, A44591-032, A44591-033, A44591-034, A44591-035, A44591-036, A44591-037, A44591-039, A44591-041, A44591-042, A44591-043, A44591-044, A44591-045, A44591-046, A44591-047, A44591-048, A44591-049, A44591-050, A44591-051, A44591-052, A44591-053, A44591-054, A44591-055, A44591-056, A44591-057, A44591-058, A44591-059, A44591-060, A44591-061, A44591-062, A44591-064, A44591-065, A44591-066, A44591-067, A44591-068, A44591-069, A44591-070, A44591-071, A44591-072, A44591-073, A44591-074, 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A55325-018, A55325-019, A55325-020, A55325-021, A55325-022, A55325-023, A55325-024, A55325-025, A55325-026, A55325-027, A55325-028, A55325-029, A55325-030, A55325-031, A55325-032, A55325-033, A55325-034, A55383-011, A55383-012, A55383-013, A55383-014, A55383-015, A55383-016, A55383-017, A55383-018, A55383-019, A55383-020, A55383-021, A55383-022, A55383-023, A55383-024, A55383-025, A55383-026, A55383-027, A55383-028, A55383-029, A55383-030, A55383-031, A55383-032, A55383-033, A55383-034, A55383-035, A55383-036, A55383-037, A55383-038, A55383-039, A55383-040, A55383-041, A55383-042, A55383-043, A55383-044, A55383-045, A55383-046, A55383-047, A55383-048, A55652-011, A55652-012, A55652-013, A55652-014, A55652-015, A55652-016, A55652-017, A55652-018, A55652-019, A55652-020, A55652-021, A55652-022, A55652-023, A55652-024, A55652-025, A55652-026, A55652-027, A55652-028, A55652-029, A55652-030, A55652-031, A55652-032, A55652-033, A55652-034, A55652-035, A55652-036, A55652-038, A55652-040, A55652-041, A55652-042, A55652-043, A55652-044, A55652-045, A55652-046, A55652-047, A55652-048, A55652-049, A55652-050, A55652-051, A55652-052, A55741-011, A55741-012, A55741-013, A55741-014, A55741-015, A55741-016, A55741-017, A55741-019, A55741-020, A55741-021, A55741-024, A55741-025, A55741-026, A55741-027, A55741-028, A55741-029, A55741-030, A55741-031, A55741-032, A55741-033, A55741-034, A55741-035, A55741-040, A55741-041, A55741-042, A55741-043, A55741-044, A55741-045, A55799-021, A55799-022, A55799-024, A55799-026, A55799-027, A55799-029, A55799-030, A55958-011, A55958-012, A55958-013, A55958-014, A55958-015, A55958-016, A55958-017, A55958-018, A55958-022, A55958-023, A55958-031, A55958-032; b) GRAFTON T50306 DBF INJECT 6CC, REF T50306, GTIN 00763000254018, Serial Numbers: A46588-011, A46588-012, A46588-013, A46588-014, A46588-015, A46588-016, A46588-017, A46588-018, A46588-019, A46588-020, A46588-021, A46588-022, A46588-023, A46588-024, A46588-025, A46588-026, A46588-027, A46588-028, A46588-029, A46588-030, A46588-031, A46588-032, A46588-033, A46588-034, A46588-035, A46588-036, A46588-037, A46588-038, A46588-039, A46588-040, A46588-041, A46588-042, A46588-043, A46655-011, A46655-012, A46655-013, A46655-014, A46655-015, A46655-016, A46655-017, A46655-018, A46655-019, A46655-020, A46655-022, A46655-023, A46655-024, A46655-025, A46655-026, A46655-027, A46655-028, A46655-029, A46655-030, A46655-031, A46655-032, A46655-033, A46655-034, A46655-035, A46655-036, A46655-037, A46655-038, A46655-040, A46655-041, A46655-042, A46655-043, A46655-044, A46655-045, A46655-046, A46655-047, A46663-011, A46663-012, A46663-013, A46663-014, A46663-015, A46663-016, A46663-017, A46663-018, A46663-019, A46663-020, A46663-021, A46663-022, A46663-023, A46663-024, A46663-025, A46663-028, A46663-029, A46663-031, A46663-032, A46663-033, A46663-034, A46663-035, A46663-036, A46663-037, A46663-038, A46663-040, A46663-041, A46663-042, A46663-043, A46663-044, A46663-045, A46811-011, A46811-012, A46811-013, A46811-014, A46811-015, A46811-016, A46811-017, A46811-018, A46811-019, A46811-020, A46811-021, A46811-022, A46811-023, A46811-024, A46811-025, A46811-028, A46811-029, A46811-030, A46811-031, A46811-032, A46811-033, A46811-034, A46811-035, A46811-036, A46811-038, A46811-039, A46811-040, A46811-041, A46811-042, A46811-043, A46811-044, A46811-045, A46811-046, A46811-047, A46811-048, A46811-049, A46811-050, A46811-051, A46811-052, A46811-053, A46811-054, A46811-055, A46811-056, A46942-011, A46942-012, A46942-013, A46942-014, A46942-015, A46942-016, A46942-017, A46942-018, A46942-019, A46942-020, A46942-021, A46942-022, A46942-023, A46942-024, A46942-025, A46942-026, A46942-027, A46942-028, A46942-029, A46942-030, A46942-031, A46942-032, A46942-033, A46942-034, A47053-011, A47053-012, A47053-013, A47053-014, A47053-015, A47053-016, A47053-017, A47053-018, A47053-019, A47053-020, A47053-021, A47053-022, A47053-023, A47053-024, A47053-025, A47053-026, A47053-027, A47053-028, A47053-029, A47053-030, A47053-031, A47053-032, A47053-033, A47053-034, A47053-035, A47053-036, A47053-037, A47053-038, A47053-039, A47053-040, A47053-041, A47053-042, A47113-011, A47113-012, A47113-013, A47113-014, A47113-015, A47113-016, A47113-017, A47113-018, A47113-019, A47113-020, A47113-021, A47113-023, A47113-024, A47113-025, A47113-026, A47113-027, A47113-028, A47113-029, A47113-030, A47113-031, A47113-032, A47113-033, A47113-034, A47113-035, A47113-036, A47113-037, A47113-038, A47113-039, A47113-040, A47113-041, A47113-042, A47113-043, A47113-044, A47113-045, A47113-046, A47113-048, A47113-049, A47113-050, A47151-011, A47151-012, A47151-013, A47151-014, A47151-016, A47151-017, A47151-018, A47151-019, A47151-020, A47151-021, A47151-022, A47151-023, A47151-024, A47151-025, A47151-026, A47151-027, A47151-028, A47151-029, A47275-026, A47275-027, A47275-028, A47275-029, A47275-030, A47275-031, A47275-032, A47275-033, A47275-034, A47275-035, A47275-036, A47275-037, A47275-038, A47275-039, A47275-040, A47275-041, A47275-042, A47275-043, A47275-044, A47275-045, A47275-047, A47275-048, A47275-049, A47275-050, A47275-051, A47275-052, A47275-053, A47275-054, A47275-055, A47275-056, A47275-057, A47275-058, A47275-059, A47275-060, A47275-062, A47275-063, A47275-064, A47275-065, A47275-066, A47275-067, A47275-068, A47275-069, A47275-070, A47275-071, A47275-072, A47275-073, A47275-074, A47275-075, A47275-076, A47275-077, A47275-078, A47275-079, A47275-080, A47275-081, A47275-082, A47428-013, A47428-014, A47428-015, A47428-016, A47428-019, A47428-020, A47428-021, A47428-022, A47428-023, A47428-024, A47428-025, A47428-026, A47428-027, A47428-028, A47428-029, A47428-030, A47428-031, A47428-032, A47428-033, A47428-035, A47428-036, A47428-037, A47428-038, A47428-039, A47428-040, A47428-041, A47428-042, A47428-043, A47721-011, A47721-012, A47721-013, A47721-014, A47721-015, A47721-016, A47721-017, A47721-018, A47721-019, A47721-020, A47721-021, A47721-022, A47721-023, A47721-024, A47721-025, A47721-026, A47721-027, A47721-028, A47721-029, A47721-030, A47721-031, A47721-032, A47721-033, A47794-011, A47794-012, A47794-013, A47794-014, A47794-015, A47794-017, A47794-018, A47794-019, A47794-020, A47794-021, A47794-022, A47794-023, A47794-024, A47794-025, A47794-026, A47794-027, A47794-028, A47794-029, A47794-030, A47794-031, A47794-032, A47794-033, A47794-034, A47794-035, A47794-036, A47794-037, A47794-038, A47794-039, A47794-040, A47794-041, A47794-042, A47794-043, A47794-044, A47794-045, A47794-046, A47871-011, A47871-012, A47871-013, A47871-014, A47871-016, A47871-017, A47871-018, A47871-019, A47871-020, A47871-021, A47871-022, A47871-023, A47871-024, A47871-025, A47871-026, A47871-027, A47871-028, A47871-029, A47871-030, A47871-031, A47871-032, A47871-033, A47871-034, A47871-035, A47871-036, A47871-037, A47871-038, A47871-039, A47871-040, A47871-041, A47871-042, A47871-043, A47871-044, A47871-045, A47871-046, A47871-047, A47871-048, A47871-049, A47871-050, A47871-051, A47871-052, A47915-011, A47915-012, A47915-013, A47915-014, A47915-015, A47915-016, A47915-017, A47915-018, A47915-019, A47915-020, A47915-021, A47915-022, A47915-023, A47915-025, A47915-026, A47915-028, A47915-029, A47915-030, A47915-031, A47915-032, A47915-033, A47915-034, A47915-035, A47915-036, A47915-037, A47915-039, A47915-040, A47915-041, A47915-042, A47915-043, A47915-045, A47915-046, A47915-047, A47915-048, A47915-049, A47915-050, A47915-051, A47915-052, A47915-053, A47915-054, A47915-055, A47915-057, A47915-058, A47915-059, A47915-060, A47915-061, A47915-062, A47915-063, A47915-064, A47915-065, A47915-066, A47915-067, A47915-068, A47915-069, A47915-070, A47915-071, A47915-072, A47915-073, A47915-074, A47915-075, A47915-076, A47915-077, A48063-011, A48063-012, A48063-013, A48063-014, A48063-015, A48063-016, A48063-017, A48063-018, A48063-019, A48063-020, A48063-021, A48063-022, A48063-023, A48063-024, A48063-025, A48063-026, A48063-027, A48063-028, A48186-011, A48186-012, A48186-013, A48186-014, A48186-015, A48186-016, A48186-017, A48186-018, A48186-019, A48186-020, A48186-021, A48186-022, A48186-023, A48186-024, A48186-025, A48186-026, A48186-027, A48186-028, A48186-029, A48186-030, A48186-031, A48186-032, A48186-033, A48186-034, A48186-035, A48186-036, A48186-039, A48186-040, A48186-042, A48186-043, A48186-044, A48186-045, A48186-046, A48186-047, A48186-049, A48186-050, A48186-051, A48186-052, A48186-053, A48186-054, A48186-055, A48186-056, A48339-026, A48339-027, A48339-028, A48339-029, A48339-030, A48339-031, A48339-032, A48339-033, A48339-034, A48339-035, A48339-036, A48339-037, A48339-038, A48339-039, A48339-040, A48339-041, A48339-042, A48339

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Brunei Darussalam, Canada, Chile, Colombia, Denmark, Dominican Republic, Ecuador, Finland, Ghana, Greece, Guatemala, Hong Kong, India, Ireland, Israel, Jamaica, Japan, Jordan, Korea, Republic Of, Kuwait, Lebanon, Liechtenstein, Luxembourg, Macao, Malaysia, Mexico, Mongolia, Namibia, Netherlands, New Zealand, Norway, Oman, Panama, Paraguay, Peru, Philippines, Portugal, Puerto Rico, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Taiwan, Thailand, Trinidad And Tobago, United Arab Emirates, United Kingdom, Viet Nam.

device · product 10 of 12

Medtronic Accelerate Grafton DBF a) ACCELERATE BG SET T50203 GRAFTON DBF 3CC, REF T50203; b) ACCELERATE BG SET T50206 GRAFTON DBF 6CC, REF T50206; c) ACCELERATE BG SET T50209 GRAFTON DBF 9CC, REF T50209; d) ACCELERATE BG SET T50212 GRAFTON DBF12CC, REF T50212; Demineralized Bone Matrix (DBM) product

Z-1332-2023
Recall number
Z-1332-2023
Initiated
February 08, 2023
Classification
Class II
Status
Ongoing
Quantity
3037 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach in the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.

Code information

a) ACCELERATE BG SET T50203 GRAFTON DBF 3CC, REF T50203, GTIN 00763000244705, Serial Numbers: A45206-011, A45206-012, A45206-013, A45206-014, A45206-016, A45206-018, A45206-019, A45206-020, A45206-021, A45206-022, A45206-023, A45206-024, A45206-025, A45206-026, A45206-027, A45206-028, A45206-029, A45206-030, A45206-031, A45206-032, A45206-033, A45206-034, A45206-035, A45206-036, A45206-037, A45206-038, A45206-040, A45206-041, A45206-042, A45206-043, A45206-045, A45206-046, A45206-047, A45206-048, A45206-049, A45206-050, A45206-051, A45206-052, A45206-053, A45206-054, A45206-055, A45206-056, A45206-057, A45206-058, A45206-061, A45206-063, A45206-064, A45206-066, A45206-067, A45206-068, A45206-069, A45206-070, A45206-071, A45206-072, A45489-011, A45489-012, A45489-015, A45489-016, A45489-017, A45489-021, A45489-022, A45489-023, A45489-024, A45489-025, A45489-026, A45489-027, A45489-028, A45489-030, A45489-032, A45489-036, A45489-037, A45489-038, A45489-039, A45489-040, A45489-041, A45489-042, A45489-045, A45489-046, A45489-047, A45489-048, A45489-049, A45489-050, A45489-051, A45870-011, A45870-012, A45870-013, A45870-014, A45870-015, A45870-016, A45870-017, A45870-018, A45870-019, A45870-020, A45870-021, A45870-022, A45870-023, A45870-025, A45870-026, A45870-027, A45870-032, A45870-033, A45870-036, A45870-038, A45870-039, A45870-040, A45870-041, A45870-042, A45870-043, A45870-044, A45870-045, A45870-046, A45870-047, A46716-036, A46716-037, A46716-038, A46716-039, A46716-040, A46716-041, A46716-042, A46716-044, A46716-046, A46716-047, A46716-048, A46716-051, A46716-054, A46716-055, A46716-056, A46716-057, A46716-058, A46716-060, A46716-061, A46716-062, A46716-065, A46716-066, A46716-067, A46716-069, A46716-070, A46716-071, A46716-072, A46716-073, A46716-074, A46716-075, A46716-076, A46716-080, A46716-081, A46716-082, A46716-083, A46716-084, A46716-085, A46716-086, A46716-087, A46716-088, A46716-089, A46716-090, A46716-091, A46716-092, A46716-093, A46716-094, A46716-095, A46716-096, A46716-107, A48729-045, A49241-011, A49241-012, A49241-013, A49241-014, A49241-016, A49241-017, A49241-018, A49241-019, A49241-020, A49241-021, A49241-022, A49241-023, A49241-024, A49241-025, A49241-026, A49241-027, A49241-028, A49241-029, A49241-030, A49241-031, A49241-032, A49241-033, A49241-034, A49241-035, A49241-036, A49241-037, A49241-038, A49241-039, A49241-040, A49241-041, A49241-042, A49241-043, A49241-044, A49241-045, A49241-046, A49241-047, A49241-048, A49241-049, A49241-050, A49241-051, A49241-052, A49241-053, A49241-054, A49241-055, A49241-056, A49241-057, A49241-058, A49241-059, A49241-060, A49241-061, A49241-062, A49241-063, A49241-064, A49241-065, A49241-067, A49241-068, A49241-069, A49241-070, A49241-071, A49241-072, A49241-073, A49241-074, A49241-076, A49241-078, A49241-079, A49241-080, A49241-081, A49241-082, A49241-083, A49241-084, A49241-086, A49241-088, A49241-089, A49241-090, A49241-091, A49241-093, A49241-095, A49241-096, A49241-098, A49241-099, A49241-100, A49241-101, A49241-102, A49241-103, A49241-104, A49241-105, A49555-011, A49555-012, A49555-013, A49555-014, A49555-022, A49555-024, A49555-026, A49555-027, A49555-028, A49555-029, A49555-030, A49555-031, A49555-032, A49555-035, A49818-011, A49818-012, A49818-013, A49818-014, A49818-015, A49818-016, A49818-017, A49818-018, A49818-020, A49818-022, A49818-023, A49818-025, A49818-026, A49818-027, A49818-028, A49818-029, A49818-030, A49818-031, A49818-032, A49818-034, A49818-035, A49818-036, A49818-037, A49818-038, A49818-039, A49818-040, A49818-041, A49818-042, A49818-043, A49818-044, A49818-045, A49818-048, A49818-049, A49818-050, A49818-051, A49818-052, A49818-053, A49818-054, A49818-055, A49818-056, A49818-057, A49818-058, A49818-059, A49818-060, A49818-061, A49818-062, A49818-063, A49818-064, A49818-065, A49818-066, A49818-067, A49818-068, A49818-069, A49818-071, A49818-072, A49818-073, A49818-074, A49818-075, A49818-076, A49818-077, A49818-079, A49818-080, A49818-081, A49818-082, A49818-083, A49818-084, A49818-085, A49818-086, A49818-087, A49818-088, A49818-089, A49818-090, A49818-091, A49818-092, A49818-093, A49818-094, A49818-095, A49818-096, A49818-097, A49818-098, A49818-099, A49818-100, A49818-101, A50197-011, A50197-014, A50197-015, A50197-017, A50197-018, A50197-019, A50197-020, A50197-021, A50197-022, A50197-024, A50197-025, A50197-026, A50197-027, A50197-028, A50197-029, A50197-030, A50197-031, A50197-032, A50197-033, A50197-034, A50197-035, A50197-036, A50197-037, A50197-038, A50197-039, A50197-040, A50197-041, A50197-042, A50197-043, A50197-047, A50197-048, A50197-049, A50197-050, A50197-051, A50197-052, A50197-053, A50197-054, A50197-055, A50197-056, A50197-057, A50197-058, A50197-059, A50197-060, A50197-061, A50197-062, A50197-063, A50197-064, A50197-065, A50197-066, A50197-067, A50197-068, A50197-069, A50197-070, A50197-071, A50197-072, A50197-073, A50197-074, A50197-075, A50197-076, A50197-077, A50197-078, A50197-079; b) ACCELERATE BG SET T50206 GRAFTON DBF 6CC, REF T50206, GTIN 00763000244712, Serial Numbers: A42287-087, A42287-088, A42287-089, A42287-090, A42287-092, A42287-093, A42287-094, A42287-095, A42287-100, A42287-101, A42287-102, A42287-103, A42287-104, A42287-105, A42287-108, A42287-112, A42287-113, A42287-114, A42287-116, A42287-117, A42287-118, A42287-119, A42287-121, A42287-122, A42287-123, A42287-124, A42287-125, A42287-126, A42287-160, A42287-161, A42287-162, A42287-163, A42287-164, A42287-165, A42287-166, A42287-167, A45179-026, A45179-027, A45179-028, A45179-029, A45179-030, A45179-031, A45179-032, A45179-033, A45179-034, A45179-036, A45179-037, A45179-038, A45179-039, A45179-040, A45179-041, A45179-042, A45179-043, A45179-044, A45179-045, A45179-046, A45179-047, A45179-048, A45179-051, A45179-052, A45179-054, A45179-055, A45179-056, A45179-057, A45179-058, A45179-059, A45179-060, A45179-061, A45179-062, A45179-063, A45179-064, A45492-013, A45492-014, A45492-015, A45492-016, A45492-017, A45492-019, A45492-020, A45492-023, A45492-024, A45492-025, A45492-026, A45492-027, A45492-028, A45492-029, A45492-031, A45492-032, A45492-033, A45492-038, A45492-039, A45492-040, A45492-041, A45492-042, A45492-043, A45492-045, A45492-046, A45492-047, A45492-048, A45492-049, A45492-050, A45492-051, A45492-052, A45492-053, A45492-054, A45492-057, A45492-058, A45492-060, A45492-062, A45492-063, A45492-064, A45492-065, A45492-066, A45492-068, A45492-070, A45492-071, A45492-072, A45492-073, A45492-074, A45492-075, A45492-076, A45492-077, A45492-078, A45492-079, A45492-080, A45492-081, A45492-084, A45492-085, A45492-086, A45492-091, A45492-092, A45492-096, A45492-097, A45492-098, A45492-099, A46669-025, A46669-028, A46669-035, A46669-037, A46669-043, A46669-044, A47321-011, A47321-012, A47321-013, A47321-014, A47321-015, A47321-016, A47321-017, A47321-018, A47321-019, A47321-020, A47321-021, A47321-022, A47321-023, A47321-024, A47321-025, A47321-026, A47321-027, A47321-028, A47321-029, A47321-030, A47321-031, A47321-032, A47321-033, A47321-034, A47321-035, A47321-036, A47321-037, A47321-038, A47321-039, A47321-040, A47321-041, A47321-042, A47321-043, A47321-044, A48003-011, A48003-012, A48003-013, A48003-014, A48003-015, A48003-016, A48003-017, A48003-018, A48003-019, A48003-020, A48003-021, A48003-022, A48003-023, A48003-024, A48003-025, A48003-026, A48003-027, A48003-028, A48003-029, A48003-030, A48003-031, A48003-032, A48003-033, A48003-034, A48003-035, A48003-036, A48003-037, A48003-039, A48003-040, A48003-041, A48003-042, A48003-043, A48003-044, A48003-045, A48003-046, A48003-047, A48003-048, A48003-049, A48003-050, A48003-051, A48003-052, A48003-053, A48003-054, A48003-055, A48003-056, A48003-057, A48003-058, A48003-059, A48003-060, A48003-061, A48003-062, A48003-063, A48003-064, A48003-065, A48003-066, A48003-067, A48003-068, A48003-069, A48003-070, A48003-071, A48003-072, A48003-073, A48003-074, A48003-075, A48003-076, A48003-077, A48003-078, A48003-079, A48003-080, A48174-012, A48174-015, A48174-016, A48174-017, A48174-018, A48174-019, A48174-020, A48174-021, A48174-022, A48174-023, A48174-024, A48174-025, A48174-026, A48174-027, A48174-028, A48174-029, A48174-030, A48174-031, A48174-032, A48174-033, A48174-034, A48174-035, A48174-036, A48174-037, A48174-038, A48174-039, A48174-041, A48174-042, A48174-043, A48174-044, A48174-045, A48174-046, A48174-047, A48174-051, A48174-054, A48174-057, A48174-058, A48174-059, A48174-060, A48174-061, A48174-062, A48174-063, A48174-064, A48174-065, A48174-066, A48174-067, A48174-068, A48174-069, A48174-070, A48174-071, A48174-072, A48174-073, A48174-074, A48174-075, A48174-076, A48174-077, A48174-078, A48174-079, A48174-080, A48174-081, A48174-082, A48174-083, A48174-084, A48174-085, A48174-086, A48174-087, A48174-088, A48174-089, A48174-090, A48174-092, A48174-093, A48174-094, A48174-095, A48174-096, A48174-097, A48174-098, A48174-099, A48174-100, A48174-101, A48174-102, A48174-103, A48174-104, A48174-105, A48174-106, A48174-107, A48174-108, A48286-016, A48286-017, A48286-018, A48286-019, A48286-020, A48286-021, A48286-022, A48286-023, A48286-024, A48286-025, A48286-026, A48286-027, A48286-028, A48286-029, A48286-030, A48286-031, A48286-032, A48286-033, A48286-034, A48286-035, A48286-036, A48286-037, A48286-038, A48286-039, A48286-040, A48286-041, A48286-042, A48286-043, A48286-044, A48286-045, A48286-046, A48286-047, A48286-048, A48286-049, A48286-050, A48286-051, A48286-052, A48286-053, A48286-054, A48286-055, A48286-056, A48286-057, A48286-058, A48286-059, A48286-060, A48286-061, A48286-062, A48286-063, A48286-064, A48286-065, A48286-066, A48286-067, A48286-068, A48286-069, A48286-070, A48286-071, A48286-072, A48286-073, A48286-074, A48286-075, A48286-076, A48286-077, A48286-078, A48286-079, A48286-080, A48286-081, A48286-082, A48286-083, A48286-084, A48286-085, A48286-086, A48286-087, A48286-088, A48286-089, A48286-090, A48286-092, A48286-093, A48286-094, A48286-095, A48286-096, A48286-097, A48286-098, A48286-099, A48286-100, A48286-101, A48286-102, A48286-103, A48286-104, A48286-105, A48286-106, A48286-107, A48286-108, A48286-109, A48286-110, A48286-111, A48286-112, A48286-113, A48286-114, A48286-115, A48286-116, A48286-117, A48286-118, A48286-119, A48286-120, A48286-121, A48286-122, A48286-123, A48967-011, A48967-012, A48967-013, A48967-014, A48967-015, A48967-016, A48967-017, A48967-018, A48967-019, A48967-020, A48967-021, A48967-022, A48967-023, A48967-024, A48967-025, A48967-026, A48967-027, A48967-028, A48967-029, A48967-030, A48967-031, A48967-032, A48967-033, A48967-034, A48967-035, A48967-036, A48967-037, A48967-038, A48967-039, A48967-040, A48967-042, A48967-043, A48967-044, A48967-045, A48967-046, A48967-047, A48967-048, A48967-049, A48967-050, A48967-051, A48967-052, A48967-053, A48967-054, A48967-055, A48967-056, A48967-057, A48967-058, A48967-059, A48967-060, A48967-062, A48967-063, A48967-064, A48967-065, A48967-066, A48967-067, A48967-068, A48967-069, A48967-070, A48967-071, A48967-072, A48967-073, A48967-074, A48967-075, A48967-076, A48967-077, A48967-078, A48967-079, A48967-080, A48967-081, A48967-082, A48967-083, A48967-084, A48967-085, A48967-086, A48967-087, A48967-088, A48967-089, A48967-090, A49028-081, A49028-082, A49028-083, A49028-084, A49028-085, A49028-086, A49028-087, A49028-088, A49028-089, A49028-090, A49028-091, A49028-092, A49028-093, A49028-094, A49028-095, A49028-096, A49028-097, A49028-098, A49028-102, A49028-103, A49028-104, A49028-105, A49028-106, A49028-107, A49028-108, A49028-109, A49028-110, A49028-111, A49028-112, A49028-113, A49028-114, A49075-011, A49075-013, A49075-014, A49075-015, A49075-016, A49075-017, A49075-018, A49075-019, A49075-020, A49075-021, A49075-022, A49075-023, A49075-026, A49075-027, A49075-030, A49075-031, A49075-032, A49075-033, A49075-034, A49075-035, A49075-036, A49075-037, A49075-039, A49075-040, A49075-041, A49075-042, A49075-043, A49075-044, A49075-045, A49075-046, A49075-047, A49075-048, A49075-049, A49075-053, A49075-054, A49075-055, A49075-056, A49075-057, A49075-058, A49075-059, A49075-060, A49075-061, A49075-062, A49075-063, A49125-011, A49125-012, A49125-014, A49125-015, A49125-016, A49125-017, A49125-018, A49125-019, A49125-024, A49125-025, A49125-026, A49125-027, A49125-031, A49125-036, A49125-037, A49125-040, A49125-041, A49125-042, A49125-043, A49125-044, A49125-045, A49125-046, A49125-049, A49125-050, A49125-051, A49125-052, A49125-053, A49125-054, A49125-055, A49125-056, A49125-057, A49125-058, A49125-059, A49125-060, A49125-061, A49125-062, A49125-063, A49125-064, A49125-065, A49125-066, A49125-069, A49125-070, A49125-071, A49125-072, A49125-073, A49125-074, A49125-075, A49125-076, A49125-077, A49125-078, A49125-079, A49125-080, A49125-083, A49125-084, A49125-085, A49125-086, A49125-087, A49125-088, A49125-089, A49125-090, A49125-091, A49125-092, A49125-093, A49125-094, A49125-095, A49125-096, A49125-097, A49125-098, A49125-099, A49125-100, A49125-101, A49125-102, A49125-103, A49125-104, A49125-105, A49125-106, A49125-107, A49125-110, A49125-111, A49125-112, A49125-113, A49125-114, A49125-115, A49125-116, A49125-117, A49176-011, A49176-012, A49176-013, A49176-014, A49176-015, A49176-016, A49176-017, A49176-018, A49176-019, A49176-020, A49176-021, A49176-022, A49176-023, A49176-028, A49176-030, A49176-031, A49176-032, A49176-033, A49176-034, A49176-035, A49176-036, A49176-037, A49176-038, A49176-039, A49176-040, A49176-041, A49176-042, A49176-043, A49176-044, A49176-045, A49176-046, A49176-047, A49176-048, A49176-049, A49176-050, A49176-051, A49176-052, A49176-053, A49176-054, A49176-055, A49176-056, A49176-057, A49176-058, A49240-011, A49240-012, A49240-013, A49240-014, A49240-015, A49240-016, A49240-017, A49240-018, A49240-019, A49240-020, A49240-021, A49240-022, A49240-023, A49240-024, A49240-025, A49240-026, A49240-027, A49240-028, A49240-029, A49240-030, A49240-031, A49240-032, A49240-033, A49240-034, A49240-035, A49240-036, A49240-037, A49240-038, A49240-039, A49240-040, A49240-041, A49240-042, A49240-043, A49240-044, A49240-045, A49240-046, A49240-047, A49240-048, A49240-049, A49240-050, A49240-051, A49240-052, A49240-053, A49240-054, A49240-055, A49240-056, A49240-057, A49240-058, A49240-059, A49240-060, A49240-061, A49240-062, A49240-063, A49240-064, A49240-065, A49240-066, A49240-067, A49240-068, A49240-069, A49240-070, A49240-071, A49240-072, A49240-073, A49240-074, A49240-075, A49240-076, A49265-011, A49265-012, A49265-013, A49265-014, A49265-015, A49265-016, A49265-017, A49265-018, A49265-019, A49265-020, A49265-021, A49265-022, A49265-023, A49265-024, A49265-025, A49265-026, A49265-027, A49265-028, A49265-029, A49265-030, A49265-031, A49265-032, A49265-033, A49265-034, A49265-035, A49265-036, A49265-037, A49265-038, A49265-039, A49265-040, A49265-041, A49265-042, A49265-043, A49265-044, A49265-045, A49265-046, A49265-047, A49265-048, A49265-049, A49265-050, A49265-051, A49265-052, A49265-053, A49265-054, A49265-055, A49265-056, A49265-057, A49265-058, A49265-059, A49265-060, A49265-061, A49265-062, A49265-063, A49265-064, A49265-065, A49265-066, A49265-067, A49265-068, A49265-069, A49265-070, A49265-074, A49265-075, A49265-076, A49265-077, A49265-078, A49265-079, A49265-080, A49265-081, A49265-082, A49265-083, A49265-084, A49265-085, A49265-086, A49265-088, A49265-089, A49265-090, A49265-091, A49265-092, A49265-093, A49265-094, A49265-095, A49265-096, A49265-097, A49265-098, A49265-099, A49265-100, A49265-101, A49265-102, A49265-103, A49265-104, A49265-105, A49265-106, A49265-107, A49265-108, A49265-109, A49265-110, A49265-111, A49265-112, A49265-113, A49265-115, A49308-011, A49308-012, A49308-013, A49308-014, A49308-015, A49308-016, A49308-017, A49308-021, A49308-022, A49308-023, A49308-024, A49308-025, A49308-026, A49308-027, A49308-028, A49308-029, A49308-030, A49308-031, A49308-032, A49308-033, A49308-034, A49308-035, A49308-036, A49308-037, A49308-038, A49308-039, A49308-040, A49308-041, A49308-042, A49308-043, A49308-044, A49308-045, A49308-046, A49308-047, A49308-048, A49308-049, A49308-050, A49308-051, A49308-054, A49308-055, A49308-056, A49308-057, A49308-058, A49308-059, A49308-060, A49308-061, A49308-062, A49308-063, A49308-064, A49308-065, A49308-066, A49308-067, A49308-068, A49308-069, A49308-070, A49308-071, A49308-072, A49308-073, A49308-074, A49308-075, A49308-076, A49308-077, A49308-078, A49308-079, A49308-081, A49308-082, A49308-083, A49308-084, A49308-085, A49308-086, A49308-087, A49308-088, A49308-089, A49308-090, A49308-091, A49308-092, A49308-093, A49308-094, A49308-095, A49308-096, A49308-097, A49308-098, A49308-099, A49308-100, A49308-101, A49308-102, A49308-103, A49308-104, A49308-105, A49308-106, A49308-107, A49308-108, A49308-109, A49308-110, A49308-111, A49308-112, A49308-113, A49308-114, A49308-115, A49308-116, A49308-117, A49308-118, A49372-011, A49372-012, A49372-013, A49372-014, A49372-015, A49372-016, A49372-017, A49372-018, A49372-019, A49372-020, A49372-021, A49372-022, A49372-023, A49372-024, A49372-025, A49372-026, A49372-027, A49372-028, A49372-029, A49372-030, A49372-031, A49372-032, A49372-033, A49372-034, A49372-035, A49372-036, A49372-037, A49372-038, A49372-039, A49372-040, A49372-041, A49372-042, A49372-043, A49372-044, A49372-045, A49372-046, A49372-048, A49372-052, A49372-053, A49372-054, A49372-057, A49372-058, A49372-059, A49372-060, A49372-061, A49372-062, A49372-063, A49372-064, A49372-065, A49372-066, A49372-067, A49372-068, A49372-069, A49372-070, A49372-071, A49372-072, A49372-073, A49372-074, A49372-075, A49372-076, A49488-011, A49488-012, A49488-013, A49488-014, A49488-015, A49488-016, A49488-017, A49488-018, A49488-019, A49488-020, A49488-022, A49488-023, A49488-024, A49488-025, A49488-026, A49488-027, A49488-028, A49488-029, A49488-030, A49488-031, A49488-032, A49488-033, A49488-034, A49488-035, A49488-036, A49488-037, A49488-038, A49488-039, A49488-040, A49488-042, A49488-043, A49488-044, A49488-045, A49488-046, A49488-047, A49488-048, A49488-049, A49488-050, A49488-051, A49488-052, A49488-053, A49488-054, A49488-055, A49488-056, A49488-057, A49488-058, A49488-059, A49488-060, A49488-061, A49488-062, A49488-063, A49488-064, A49488-065, A49488-066, A49488-069, A49488-070, A49488-071, A49488-072, A49488-073, A49488-074, A49488-075, A49488-076, A49488-077, A49492-011, A49492-012, A49492-013, A49492-014, A49492-015, A49492-016, A49492-017, A49492-018, A49492-019, A49492-020, A49492-021, A49492-022, A49492-023, A49492-024, A49492-025, A49492-026, A49492-028, A49492-029, A49492-030, A49492-031, A49492-032, A49492-033, A49492-034, A49492-035, A49492-036, A49492-037, A49492-038, A49492-039, A49492-040, A49492-041, A49492-042, A49492-043, A49492-044, A49492-045, A49492-046, A49492-047, A49492-048, A49492-049, A49492-050, A49492-051, A49492-052, A49492-054, A49492-055, A49492-056, A49492-057, A49492-058, A49492-059, A49492-060, A49492-061, A49492-062, A49492-063, A49492-064, A49492-065, A49492-066, A49492-067, A49492-068, A49492-069, A49492-070, A49492-071, A49492-072, A49492-073, A49492-074, A49492-075, A49492-076, A49492-077, A49492-078, A49492-079, A49492-080, A49549-012, A49549-013, A49549-014, A49549-015, A49549-016, A49549-030, A49549-037, A49549-039, A49549-040, A49549-041, A49549-042, A49549-043, A49549-044, A49549-045, A49549-046, A49549-047, A49549-048, A49549-092, A49549-102, A49665-011, A49665-012, A49665-013, A49665-014, A49665-015, A49665-016, A49665-017, A49665-018, A49665-019, A49665-020, A49665-021, A49665-022, A49665-023, A49665-024, A49665-025, A49665-026, A49665-028, A49665-029, A49665-034, A49665-035, A49665-036, A49665-037, A49665-038, A49665-039, A49665-040, A49665-043, A49665-044, A49665-045, A49665-046, A49665-047, A49665-048, A49665-049, A49665-050, A49665-051, A49665-052, A49665-053, A49665-056, A49665-058, A49665-059, A49665-061, A49665-062, A49665-063, A49665-064, A49665-065, A49665-066, A49665-067, A49665-068, A49665-069, A49665-070, A49665-071, A49665-072, A49665-073, A49665-074, A49665-075, A49665-076, A49665-077, A49665-078, A49665-079, A49665-080, A49665-081, A49665-082, A49665-083, A49665-084, A49665-085, A49822-012, A49822-013, A49822-014, A49822-015, A49822-016, A49822-017, A49822-018, A49822-019, A49822-021, A49822-022, A49822-023, A49822-024, A49822-027, A49822-028, A49822-029, A49822-030, A49822-031, A49822-032, A49822-033, A49822-034, A49822-035, A49822-036, A49822-037, A49822-038, A49822-039, A49822-040, A49822-041, A49822-042, A49822-043, A49822-044, A49822-045, A49822-046, A49822-047, A49822-048, A49822-049, A49822-050, A49822-052, A49822-054, A49822-055, A49822-056, A49822-057, A49822-058, A49822-059, A49822-061, A49822-062, A49822-063, A49822-064, A49822-065, A49822-066, A49822-067, A49822-068, A49822-069, A49822-070, A49822-071, A49822-072, A49822-073, A49822-074, A49822-075, A49822-076, A49822-077, A49822-078, A49822-079, A49822-080, A50132-011, A50132-012, A50132-013, A50132-014, A50132-015, A50132-016, A50132-017, A50132-018, A50132-019, A50132-020, A50132-021, A50132-022, A50132-023, A50132-024, A50132-025, A50132-026, A50132-027, A50132-028, A50132-029, A50132-030, A50132-031, A50132-032, A50132-033, A50132-034, A50132-035, A50132-036, A50132-037, A50132-038, A50132-039, A50132-040, A50132-041, A50132-042, A50132-043, A50132-044, A50132-045, A50132-046, A50132-047, A50132-048, A50132-049, A50132-050, A50132-051, A50132-052, A50132-053, A50132-054, A50132-055, A50132-056, A50132-057, A50132-058, A50132-059, A50132-060, A50132-061, A50132-062, A50132-063, A50132-064, A50132-065, A50132-066, A50132-067, A50132-068, A50132-069, A50132-070, A50132-071, A50132-072, A50132-073, A50132-074, A50132-075, A50132-076, A50132-077, A50132-078, A50132-079, A50132-080, A50132-081, A50132-082, A50132-083, A50132-084, A50132-085, A50132-086, A50132-087, A50132-088, A50132-089, A50132-090, A50132-091, A50132-092, A50132-093, A50132-094, A50132-095, A50132-096, A50132-097, A50132-098, A50132-099, A50132-100, A50132-101, A50224-011, A50224-012, A50224-013, A50224-014, A50224-015, A50224-016, A50224-019, A50224-020, A50224-021, A50224-022, A50224-023, A50224-024, A50224-025, A50224-026, A50224-027, A50224-028, A50224-029, A50224-030, A50224-031, A50224-032, A50224-033, A50224-034, A50224-035, A50224-036, A50224-037, A50224-038, A50224-039, A50224-040, A50224-042, A50224-043, A50224-044, A50224-045, A50224-046, A50224-047, A50224-048, A50224-049, A50224-053, A50224-054, A50224-055, A50224-056, A50224-057, A50224-058, A50224-059, A50224-060, A50224-061, A50224-062, A50224-063, A50224-064, A50224-065, A50224-066, A50224-067, A50224-068, A50224-069, A50224-070, A50299-011, A50299-012, A50299-013, A50299-014, A50299-015, A50299-016, A50299-017, A50299-018, A50299-019, A50299-020, A50299-023, A50299-024, A50299-025, A50299-026, A50299-027, A50299-028, A50299-029, A50299-030, A50299-031, A50299-033, A50299-034, A50299-037, A50299-038, A50299-039, A50299-040, A50299-041, A50299-042, A50299-043, A50299-044, A50299-045, A50299-046, A50299-047, A50299-048, A50299-049, A50299-050, A50299-051, A50299-052, A50299-053, A50299-054, A50299-055, A50299-056, A50299-057, A50299-058, A50299-059, A50299-060, A50299-061, A50299-065, A50299-067, A50299-068, A50299-069, A50299-070, A50299-071, A50299-072, A50299-073, A50299-074, A50299-075, A50299-076, A50299-077, A50299-078, A50299-079, A50299-080, A50299-081, A50299-082, A50299-083, A50299-084, A50299-085, A50299-086, A50299-087, A50299-088, A50299-089, A50299-090, A50299-091, A50299-092, A50299-093, A50299-094, A50299-095, A50299-096, A50299-097, A50299-098, A50299-099, A50299-100, A50299-101, A50784-029, A50784-030; c) ACCELERATE BG SET T50209 GRAFTON DBF 9CC, REF T50209, GTIN 00763000244729, Serial Numbers: A45398-036, A45398-037, A45398-038, A45398-039, A45398-040, A45398-041, A45398-042, A45398-043, A45398-044, A45398-045, A45398-046, A45398-047, A45398-048, A45398-049, A46088-011, A46088-012, A46088-013, A46088-014, A46088-015, A46088-016, A46088-017, A46088-018, A46088-019, A46088-020, A46088-021, A46088-022, A46088-023, A46088-024, A46088-025, A46088-026, A46088-027, A46088-029, A46088-030, A46088-031, A46088-032, A46088-033, A46088-034, A46088-035, A46088-036, A46088-037, A46088-038, A46088-039, A46088-040, A46088-042, A46088-043, A46088-044, A46088-045, A46948-011, A46948-012, A46948-015, A46948-017, A46948-018, A46948-019, A46948-020, A46948-021, A46948-022, A46948-023, A46948-026, A46948-027, A46948-028, A46948-029, A46948-030, A46948-031, A46948-032, A46948-033, A46948-034, A46948-039, A46948-040, A46948-041, A46948-042, A46948-043, A46948-044, A46948-046, A46948-047, A46948-048, A46948-049, A46948-051, A46948-053, A46948-054, A48537-048, A48537-049, A48537-050, A48537-051, A48537-052, A48537-053, A48537-054, A48537-055, A48537-056, A48537-057, A48537-058, A48537-059, A48537-060, A48537-061, A48537-062, A48537-063, A48537-064, A48537-065, A48537-066, A48537-067, A48537-068, A48537-069, A48537-072, A48537-073, A48537-074, A48537-075, A48537-076, A48537-077, A48537-078, A48537-079, A48537-082, A49119-011, A49119-012, A49119-013, A49119-014, A49119-015, A49119-016, A49119-017, A49119-018, A49119-019, A49119-020, A49119-021, A49119-022, A49119-023, A49119-024, A49119-025, A49119-026, A49119-027, A49119-028, A49119-029, A49119-030, A49119-031, A49119-032, A49119-033, A49119-035, A49119-036, A49119-038, A49119-039, A49119-040, A49119-042, A49119-043, A49119-044, A49119-045, A49119-046, A49119-047, A49119-048, A49119-049, A49119-050, A49409-011, A49409-012, A49409-013, A49409-014, A49409-015, A49409-016, A49409-017, A49409-018, A49409-019, A49409-020, A49409-021, A49409-022, A49409-023, A49409-024, A49409-025, A49409-026, A49409-027, A49409-028, A49409-029, A49409-030, A49409-031, A49409-033, A49409-034, A49409-035, A49409-036, A49409-037, A49409-038, A49409-039, A49409-041, A49409-042, A49409-043, A49409-044, A49409-045, A49409-046, A49409-047, A49409-048, A49409-049, A49409-050, A49409-051, A49409-052, A49409-053, A49409-054, A49409-055, A49409-056, A49409-057, A49409-058, A49409-059, A49554-011, A49554-012, A49554-013, A49554-014, A49554-015, A49554-020, A49554-021, A49554-022, A49554-023, A49554-024, A49554-025, A49554-026, A49554-027, A49554-028, A49554-029, A49554-030, A49554-031, A49554-032, A49554-033, A49554-034, A49554-036, A49554-037, A49554-038, A49554-039, A49554-040, A49554-041, A49554-042, A49554-043, A49554-044, A49554-045, A49554-046, A49554-047, A49554-048, A49554-050, A49554-051, A49554-052, A49554-053, A49554-054, A49554-055, A49554-056, A49554-057, A49554-058, A49554-059, A49554-060, A49554-063, A49554-065, A49554-066, A49606-011, A49606-012, A49606-013, A49606-014, A49606-015, A49606-016, A49606-017, A49606-020, A49606-021, A49606-022, A49606-023, A49606-024, A49606-025, A49606-026, A49606-027, A49606-028, A49606-029, A49606-030, A49606-032, A49606-033, A49606-034, A49606-035, A49606-036, A49606-037, A49606-038, A49606-039, A49606-040, A49606-041, A49606-042, A49606-043, A49606-044, A49606-045, A49606-046, A49606-047, A49606-048, A49606-049, A49606-050, A49606-051, A49606-052, A49606-053, A49606-055, A49606-056, A49606-058, A49606-059, A49606-060, A49606-061, A49606-065, A49606-066, A49606-067, A49606-069, A49606-070, A49652-012, A49652-018, A49652-019, A49652-021, A49652-022, A49652-023, A49652-024, A49652-025, A49652-026, A49652-027, A49652-028, A49652-029, A49652-032, A49652-033, A49652-034, A49652-035, A49652-036, A49652-037, A49652-038, A49652-039, A49652-040, A49652-041, A49652-042, A49652-043, A49652-044, A49652-045, A49652-046, A49652-047, A49652-048, A49652-049, A49652-051, A49652-052, A49652-053, A49652-055, A49652-056, A49652-057, A49652-058, A49652-059, A49652-060, A49652-061, A49652-062, A49652-063, A49652-064, A49652-065, A49652-066, A49707-036, A49707-037, A49707-038, A49707-039, A49707-041, A49707-042, A49707-045, A49707-046, A49707-047, A49707-048, A49707-049, A49707-050, A49707-051, A49707-052, A49707-053, A49707-054, A49707-055, A49707-056, A49707-057, A49707-058, A49707-059, A49707-060, A49707-061, A49707-062, A49707-063, A49810-011, A49810-012, A49810-013, A49810-014, A49810-015, A49810-016, A49810-017, A49810-018, A49810-019, A49810-021, A49810-023, A49810-026, A49810-027, A49810-028, A49810-029, A49810-030, A49810-031, A49810-032, A49810-033, A49810-034, A49810-036, A49810-038, A49810-040, A49810-041, A50025-012, A50025-013, A50025-014, A50025-015, A50025-016, A50025-017, A50025-018, A50025-019, A50025-020, A50025-021, A50025-022, A50025-023, A50025-024, A50025-025, A50025-026, A50025-027, A50025-029, A50025-030, A50025-031, A50025-032, A50025-033, A50025-034, A50025-035, A50025-036, A50025-037, A50025-038, A50025-039, A50025-040, A50025-041, A50025-042, A50025-043, A50025-044, A50025-045, A50025-046, A50025-047, A50025-048, A50025-049, A50025-050, A50025-051, A50025-052, A50025-053, A50025-054, A50025-055, A50025-056, A50025-057, A50025-058, A50025-059, A50025-060, A50025-061, A50473-011, A50473-012, A50473-013, A50473-014, A50473-015, A50473-016, A50473-017, A50473-018, A50473-019, A50473-020, A50473-021, A50473-022, A50473-023, A50473-024, A50473-025, A50473-026, A50473-027, A50473-028, A50473-029, A50473-030, A50473-031, A50473-032, A50473-033, A50473-034, A50473-035, A50473-036, A50473-037, A50473-038, A50473-039, A50473-040, A50473-041, A50473-042, A50473-043, A50473-044, A50473-045, A50473-046, A50473-047, A50574-011, A50574-012, A50574-013, A50574-014, A50574-015, A50574-028, A50574-029, A50574-030, A50574-031, A50574-032, A50574-033, A50574-034, A50574-035, A50574-036, A50574-037, A50574-038, A50574-039, A50574-041, A50574-042, A50574-043, A50574-044, A50574-045, A50574-046, A50574-047, A50574-048, A50574-049, A50574-050, A50574-051, A50574-052, A50574-053, A50574-054, A50574-055, A50574-056, A50574-057, A50574-058, A50574-059, A50584-011, A50584-012, A50584-013, A50584-014, A50584-015, A50584-017, A50584-018, A50584-019, A50584-020, A50584-021, A50584-022, A50584-023, A50584-024, A50584-025, A50584-026, A50584-027, A50584-028, A50584-036, A50584-037, A50584-038, A50584-039, A50591-011, A50591-012, A50591-013, A50591-015, A50591-016, A50591-017, A50591-018, A50591-019, A50591-020, A50591-021, A50591-022, A50591-023, A50591-024, A50591-025, A50591-026, A50591-028, A50591-032, A50591-033, A50591-034, A50591-035, A50591-036, A50591-044, A50591-053, A50627-011, A50627-012, A50627-013, A50627-014, A50627-015, A50627-016, A50627-017, A50627-018, A50627-019, A50627-020, A50627-021, A50627-022, A50627-023, A50627-024, A50627-025, A50627-026, A50627-028, A50627-029, A50627-030, A50627-031, A50627-033, A50627-035, A50627-036, A50627-037, A50627-038, A50627-039, A50627-040, A50627-042, A50627-043, A50627-044, A50627-045, A50627-046, A50627-047, A50627-048, A50627-049, A50627-050, A50627-051, A50627-052, A50627-053, A50627-054, A50627-055, A50784-043, A50784-075, A51290-012, A51290-013, A51290-014, A51290-015, A51290-021, A51290-022, A51290-023, A51290-024, A51290-025, A51290-026, A51290-027, A51290-028, A51290-029, A51290-030, A51290-031, A51290-034, A51290-035, A51290-036, A51290-037, A51290-038, A51290-039, A51290-040, A51290-041, A51290-042, A51290-043, A51290-044, A51290-045, A51290-046, A51290-047, A51290-048, A51290-049, A51290-050, A51290-051, A51290-052, A51290-053, A51290-054, A51290-055, A51290-056, A51290-057, A51290-058, A51290-059, A51290-060, A51290-061, A51290-062, A51290-063; d) ACCELERATE BG SET T50212 GRAFTON DBF12CC, REF T50212, GTIN 00763000244736, Serial Numbers: A45398-050, A45398-051, A45398-052, A45398-053, A45398-054, A45398-055, A45398-056, A45398-057, A45398-058, A45398-059, A45398-060, A45398-061, A45398-062, A45398-063, A45930-031, A45930-032, A45930-033, A45930-034, A45930-035, A45930-036, A45930-037, A45930-038, A45930-039, A45930-040, A45930-041, A45930-042, A45930-043, A45930-044, A45930-045, A45930-046, A45930-047, A45930-048, A45930-049, A45930-050, A45930-051, A45930-052, A47605-013, A47605-015, A47605-016, A47605-017, A47605-020, A47605-021, A47605-023, A47605-024, A47605-031, A47605-032, A47605-037, A47605-038, A47687-012, A47687-013, A47687-014, A47687-015, A47687-016, A47687-017, A47687-018, A47687-019, A47687-020, A47687-024, A47687-025, A47687-026, A47687-027, A47687-028, A47687-029, A47687-030, A47687-031, A47687-032, A47687-033, A47687-034, A47687-035, A47687-036, A47687-037, A47687-038, A47687-039, A47687-040, A48349-012, A48349-013, A48349-014, A48349-015, A48349-016, A48349-017, A48349-019, A48349-020, A48349-021, A48349-022, A48349-023, A48349-024, A48349

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Brunei Darussalam, Canada, Chile, Colombia, Denmark, Dominican Republic, Ecuador, Finland, Ghana, Greece, Guatemala, Hong Kong, India, Ireland, Israel, Jamaica, Japan, Jordan, Korea, Republic Of, Kuwait, Lebanon, Liechtenstein, Luxembourg, Macao, Malaysia, Mexico, Mongolia, Namibia, Netherlands, New Zealand, Norway, Oman, Panama, Paraguay, Peru, Philippines, Portugal, Puerto Rico, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Taiwan, Thailand, Trinidad And Tobago, United Arab Emirates, United Kingdom, Viet Nam.

device · product 11 of 12

Medtronic Grafton Gel: a) DBM S41120 GRAFTON GEL 1CC, REF S41120; b) DBM S41150 GRAFTON GEL 10CC, REF S41150; c) DBM T41110 0.5CC GRAFTON GEL, REF T41110; d) DBM T41110INT 0.5CC GRAFTON GEL, REF T41110INT; e) DBM T41120 1CC GRAFTON GEL, REF T41120; f) DBM T41120INT 1CC GRAFTON GEL, REF T41120INT; g) DBM T41130 5CC GRAFTON GEL, REF T41130; h) DBM T41130INT 5CC GRAFTON GEL, REF T41130INT; i) DBM T41150 10CC GRAFTON GEL, REF T41150; j) DBM T41150INT 10CC GRAFTON GEL, REF T41150INT; Demineralized Bone Matrix (DBM) product

Z-1333-2023
Recall number
Z-1333-2023
Initiated
February 08, 2023
Classification
Class II
Status
Ongoing
Quantity
10090 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach in the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.

Code information

a) DBM S41120 GRAFTON GEL 1CC, REF S41120, GTIN 00613994961167, Serial Numbers: A41879 b) DBM S41150 GRAFTON GEL 10CC, REF S41150, GTIN 00613994961143, Serial Numbers: A43939, A47225 c) DBM T41110 0.5CC GRAFTON GEL, REF T41110, GTIN 00643169122956, Serial Numbers: A38528-100, A38528-101, A38528-102, A38528-103, A38528-104, A38528-105, A38528-106, A38910-058, A38910-059, A38910-060, A38910-061, A38910-062, A41224-053, A41224-054, A41224-055, A41224-056, A41224-057, A41224-058, A41224-059, A41224-060, A41224-061, A41224-062, A41224-063, A41224-064, A41224-065, A41224-066, A41224-067, A41224-068, A41224-069, A41224-070, A41224-071, A41224-072, A41935-025, A41935-026, A41935-027, A41935-028, A41935-029, A41935-030, A41935-031, A41935-032, A41935-033, A41935-034, A41935-035, A41935-036, A41935-037, A41935-038, A41935-039, A41935-040, A41935-041, A41935-042, A41935-043, A41935-044, A41935-045, A41935-046, A41935-047, A41935-048, A41935-049, A41935-050, A41935-051, A41935-052, A41935-053, A42221-076, A42221-077, A42221-078, A42221-079, A42221-080, A42221-081, A42221-082, A42221-083, A42221-084, A42221-085, A42619-011, A42619-012, A42619-013, A42619-014, A42619-015, A42619-016, A42619-017, A42619-018, A42619-019, A42619-020, A42619-021, A42619-022, A42619-023, A42619-024, A42619-025, A42619-026, A42619-027, A42619-028, A42619-029, A42619-030, A42619-031, A42619-032, A42619-033, A42619-034, A42619-035, A42619-036, A43231-127, A43231-128, A43286-011, A43286-012, A43286-013, A43286-014, A43286-015, A43286-016, A43286-017, A43286-018, A43286-019, A43286-020, A43286-021, A43286-022, A43286-023, A43286-024, A43286-025, A43286-026, A43286-027, A43286-028, A43286-029, A43286-030, A43286-031, A43286-032, A43286-033, A43286-034, A43286-035, A43286-036, A43286-037, A43286-038, A43286-039, A43286-040, A43286-041, A43286-042, A43286-043, A43286-044, A43286-045, A43286-046, A43286-047, A43286-048, A43286-049, A43286-050, A43286-051, A43286-052, A43286-053, A43286-054, A43286-055, A43286-056, A43286-057, A43286-058, A43286-059, A43286-060, A43286-061, A46158-011, A46158-012, A46158-013, A46158-014, A46158-015, A46158-016, A46158-017, A46158-018, A46158-019, A46158-020, A46158-021, A46158-022, A46158-023, A46158-024, A46158-025, A46158-026, A46158-027, A46158-028, A46158-029, A46158-030, A46158-031, A46158-032, A46158-033, A46158-034, A46158-035, A46158-036, A46158-037, A46158-038, A46158-039, A46158-040, A46158-041, A46158-042, A46158-043, A46158-044, A46158-045, A46158-046, A46158-047, A46158-048, A46158-049, A46158-050, A46158-051, A46158-052, A46158-053, A46158-054, A46158-055, A46158-056, A47115-011, A47115-012, A47115-013, A47115-014, A47115-015, A47115-016, A47115-017, A47115-018, A47115-019, A47115-020, A47115-021, A47115-022, A47115-023, A47115-024, A47115-025, A47115-026, A47115-027, A47115-028, A47115-029, A47115-030, A47115-031, A47115-032, A47115-033, A47115-034, A47115-035, A47115-036, A47115-037, A47115-038, A47115-039, A47115-040, A47293-011, A47293-012, A47293-013, A47293-014, A47293-015, A47293-016, A47293-017, A47293-018, A47293-019, A47293-020, A47293-021, A47293-022, A47293-023, A47293-024, A47293-025, A47293-026, A47293-027, A47293-028, A47293-029, A47293-030, A47293-031, A47293-032, A47293-033, A47293-034, A47293-035, A47293-036, A47431-041, A47431-042, A47431-043, A47431-044, A47431-045, A47431-046, A47431-047, A47431-048, A47431-049, A47431-050, A47431-051, A47431-052, A47431-053, A47431-054, A47431-055, A47431-056, A47431-057, A47431-058, A47431-059, A47431-060, A47431-061, A47431-062, A47431-063, A47431-064, A47431-065, A47431-066, A47431-067, A47431-068, A47431-069, A47431-070, A47431-071, A47431-072, A47431-073, A47431-074, A47431-075, A47431-076, A47431-077, A47431-078, A47431-079, A47431-080, A47431-081, A47431-082, A47573-030, A47573-031, A47573-032, A47573-033, A47573-034, A47573-035, A47573-036, A47573-037, A47573-038, A47573-039, A47573-040, A47573-041, A47573-042, A47573-043, A47573-044, A47573-045, A47573-046, A47573-047, A47573-048, A47573-049, A47573-050, A47573-051, A47573-052, A47573-053, A47573-054, A47573-055, A47573-056, A47573-057, A47573-058, A47573-059, A47573-060, A47573-061, A47573-062, A47573-063, A47573-064, A47573-065, A47573-066, A47573-067, A47573-068, A47573-069, A47573-070, A47573-071, A47573-072, A47573-073, A47573-074, A47573-075, A47573-076, A47573-077, A47573-078, A47573-079, A47573-080, A47573-081, A47573-082, A47573-083, A47573-084, A47573-085, A47573-086, A47573-087, A47573-088, A47573-089, A47573-090, A47573-091, A47573-092, A47573-093, A47573-094, A47573-095, A47672-060, A47672-061, A47672-062, A47672-063, A47672-064, A47672-065, A47672-066, A47672-067, A47672-068, A47672-069, A47672-070, A47672-071, A47672-072, A47672-073, A47672-074, A47672-075, A47672-076, A47672-077, A47672-078, A47672-079, A47672-080, A47672-081, A47672-082, A47672-083, A47672-084, A47672-085, A47672-086, A47672-087, A47672-088, A47672-089, A47672-090, A47672-091, A47672-092, A47672-093, A47672-094, A48441-046, A48441-047, A48441-048, A48441-049, A48441-050, A48441-051, A48441-052, A48441-053, A48441-054, A48441-055, A48441-056, A48441-057, A48441-058, A48441-059, A48441-060, A48441-061, A48441-062, A48441-063, A48441-064, A48441-065, A48441-066, A48441-067, A48441-068, A48441-069, A48441-070, A48441-071, A48441-072, A48441-073, A48441-074, A48441-075, A48441-076, A48441-077, A48441-078, A48441-079, A48441-080, A48441-081, A48441-082, A48441-083, A48441-084, A48441-085, A48441-086, A48441-087, A48441-088, A48441-089, A48441-090, A48441-091, A48538-115, A48538-116, A48538-117, A48538-118, A48538-119, A48538-120, A48538-121, A48538-122, A48538-123, A48538-124, A48538-125, A48538-126, A48538-127, A48538-128, A48538-129, A48538-130, A48538-131, A48538-132, A48538-133, A48538-134, A48538-135, A48538-136, A48538-137, A48538-138, A48538-139, A48538-140, A48538-141, A48538-142, A48538-143, A48538-144, A48538-145, A48538-146, A48538-147, A48538-148, A48538-149, A48538-150, A49912-056, A49912-057, A49912-058, A49912-059, A49912-060, A49912-061, A49912-062, A49912-063, A49912-064, A49912-065, A49912-066, A49912-067, A49912-068, A49912-069, A49912-070, A49912-071, A49912-072, A49912-073, A49912-074, A49912-075, A49912-076, A49912-077, A49912-078, A49912-079, A49912-080, A49912-081, A49912-082, A49912-083, A49912-084, A49912-085, A49912-086, A49912-087, A49912-088, A49912-089, A49912-090, A49912-091, A49912-092, A49912-093, A49975-051, A49975-052, A49975-053, A49975-054, A49975-055, A49975-056, A49975-057, A49975-058, A49975-059, A49975-060, A49975-061, A49975-062, A49975-063, A49975-064, A49975-065, A49975-066, A49975-067, A49975-068, A49975-069, A49975-070, A49975-071, A49975-072, A49975-073, A49975-074, A49975-075, A49975-076, A49975-077, A49975-078, A49975-079, A52779-011, A52779-012, A52779-013, A52779-014, A52779-015, A52779-016, A52779-017, A52779-018, A52779-019, A52779-020, A52779-021, A52779-022, A52779-023, A53118-021, A53118-022, A53118-023, A53118-024, A53118-025, A53118-026, A53118-027, A53118-028, A53118-029, A53118-030, A53118-031, A53118-032, A53118-033, A53118-034, A53118-035, A53118-036, A53118-037, A53118-038, A53118-039, A53118-040, A53118-041, A53118-042, A53118-043, A53118-044, A53118-045, A53118-046, A53118-047, A53118-048, A53118-049, A53118-050, A53118-051, A53118-052, A53118-053, A53118-054, A53118-055, A53118-056, A53118-057, A53118-058, A53118-059, A53118-060, A53118-061, A53118-062, A53118-063, A53118-064, A53118-065, A53118-066, A53118-067, A53118-068, A53118-069, A53118-070, A53118-071, A53118-072, A53118-073, A53118-074, A53118-075, A53118-076, A53118-077, A53118-078, A53118-079, A53118-080, A53118-081, A53177-011, A53177-012, A53177-013, A53177-014, A53177-015, A53177-016, A53177-017, A53177-018, A53177-019, A53177-020, A53177-021, A53177-022, A53177-023, A53177-024, A53177-025, A53177-026, A54244-064, A54244-065, A54244-066, A54244-067, A54244-068, A54244-069, A54244-070, A54244-071, A54244-072, A54244-073, A54350-034, A54350-035, A54350-036, A54350-037, A54350-038, A54350-039, A54350-040, A54350-041, A54350-042, A54350-043, A54350-044, A54350-045, A54350-067, A54350-068, A54350-069, A54350-070; d) DBM T41110INT 0.5CC GRAFTON GEL, REF T41110INT, GTIN 00643169964839, Serial Numbers: A37724-094, A37724-095, A37724-096, A37724-097, A37724-098, A37724-099, A37724-100, A37724-101, A37724-102, A37724-103, A37724-104, A37724-105, A37724-106, A37724-107, A37724-108, A37724-109, A37724-110, A37724-111, A37724-112, A37724-113, A37724-114, A37724-115, A37724-116, A37724-117, A37724-118, A37724-119, A37724-120, A37724-121, A37724-122, A37724-123, A37724-124, A37724-125, A37724-126, A39537-031, A39537-032, A39537-033, A39537-034, A39537-035, A39537-036, A39537-037, A39537-038, A39537-039, A39537-040, A39537-041, A39537-042, A39537-043, A39537-044, A39537-045, A39537-046, A39537-047, A39537-048, A39537-049, A39537-050, A39537-051, A39537-052, A39537-053, A42444-041, A42444-042, A42444-043, A42444-044, A42444-045, A42444-046, A42444-047, A42444-048, A42444-049, A42444-050, A42444-051, A42444-052, A42571-102, A42571-103, A42571-104, A42571-105, A42571-106, A42571-107, A42571-108, A42571-109, A42780-068, A42780-069, A42780-070, A42780-071, A42780-072, A42780-073, A42780-074, A42780-075, A42780-076, A42780-077, A42780-078, A42780-079, A42780-080, A42780-081, A42780-082, A42780-083, A42780-084, A42780-085, A42780-086, A42780-087, A42780-088, A42780-089, A42780-090, A42780-091, A42780-092, A42780-093, A42780-094, A42780-095, A42780-096, A42780-097, A42780-098, A42780-099, A42780-100, A42780-101, A43098-042, A43098-043, A43098-044, A43098-045, A43098-046, A43098-047, A43098-048, A43098-049, A43098-050, A43098-051, A43098-052, A43098-053, A43098-054, A43098-055, A43098-056, A43098-057, A43098-058, A43098-059, A43098-060, A43098-061, A43098-062, A43098-063, A43098-064, A43284-036, A43284-037, A43284-038, A43284-039, A43284-040, A43284-041, A43284-042, A43284-043, A43284-044, A43284-045, A43286-067, A43286-068, A43286-069, A43286-070, A43286-071, A43286-072, A43286-073, A43286-074, A43286-075, A43286-076, A43286-077, A43286-078, A43286-079, A43286-080, A43286-081, A43286-082, A43858-011, A43858-012, A43858-013, A43858-014, A43858-015, A43858-016, A43858-017, A43858-018, A43858-019, A43858-020, A43858-021, A43858-022, A43858-023, A43858-024, A43858-025, A43858-026, A43858-027, A43858-028, A43858-029, A43858-030, A43858-031, A43858-032, A43858-033, A43858-034, A43858-035, A43858-036, A43858-037, A43858-038, A43858-039, A43858-040, A43858-041, A43858-042, A43858-043, A43858-044, A43858-045, A43858-046, A43858-047, A43858-048, A43858-049, A43858-050, A43858-051, A43858-052, A43858-053, A43858-054, A43858-055, A43858-056, A43858-057, A43858-058, A43858-059, A43858-060, A43858-061, A44260-011, A44260-012, A44260-013, A44260-014, A44260-015, A44260-016, A44260-017, A44260-018, A44260-019, A44260-020, A44260-021, A44260-022, A44260-023, A44260-024, A44260-025, A46158-057, A46158-058, A46158-059, A46158-060, A46158-061, A46158-062, A46158-063, A46158-064, A46158-065, A46158-066, A46333-031, A46333-032, A46333-033, A46333-034, A46333-035, A46333-036, A46333-037, A46333-038, A46333-039, A46333-040, A46333-041, A46333-042, A46333-043, A46333-044, A46333-045, A46333-046, A46333-047, A46333-048, A46333-049, A46333-050, A46333-051, A46333-052, A46333-053, A46791-011, A46791-012, A46791-013, A46791-014, A46791-015, A46791-016, A46791-017, A46791-018, A46791-019, A46791-020, A46791-021, A46791-022, A46791-023, A46791-024, A46791-025, A46791-026, A46791-027, A47034-041, A47034-042, A47034-043, A47034-044, A47034-045, A47034-046, A47034-047, A47034-048, A47034-049, A47034-050, A47034-051, A47034-052, A47034-053, A47034-054, A47034-055, A47034-056, A47034-057, A47034-058, A47034-059, A47034-060, A47034-061, A47034-062, A48114-084, A48114-085, A48114-086, A48114-087, A48114-088, A48114-089, A48114-090, A48114-091, A48114-092, A48114-093, A48114-094, A48114-095, A48114-096, A48114-097, A48114-098, A48114-099, A48114-100, A48114-101, A48699-011, A48699-012, A48699-013, A48699-014, A48699-015, A48699-016, A48699-017, A48699-018, A48699-019, A48699-020, A48699-021, A48699-022, A48699-023, A48699-024, A48699-025, A48699-026, A48699-027, A48699-028, A48699-029, A48699-030, A48699-031, A48699-032, A49529-011, A49529-012, A49529-013, A49529-014, A49529-015, A49529-016, A49529-017, A49529-018, A49529-019, A49529-020, A49529-021, A49529-022, A49529-023, A49529-024, A49529-025, A49529-026, A49529-027, A49529-028, A49529-029, A51547-041, A51547-042, A51547-043, A51547-044, A51547-045, A51547-046, A51547-047, A51547-048, A53185-011, A53185-012, A53185-013, A53185-014, A53185-015; e) DBM T41120 1CC GRAFTON GEL, REF T41120, GTIN 00643169122963, Serial Numbers: A38528-107, A38528-108, A38528-109, A38528-110, A38528-111, A38528-112, A38528-113, A38528-114, A38528-115, A38528-116, A38528-117, A38528-118, A38528-119, A38528-120, 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A39248-213, A39248-214, A39248-215, A39248-216, A39248-217, A39248-219, A39248-220, A39248-221, A39248-222, A39248-223, A39248-224, A39248-225, A39248-226, A39248-227, A39248-228, A39248-229, A39248-230, A39248-231, A39248-232, A39248-233, A39248-234, A39248-235, A39248-236, A40738-117, A40738-118, A40738-119, A40738-120, A40738-121, A40738-122, A40738-123, A40738-124, A40738-125, A40738-126, A40738-127, A40738-128, A40738-129, A40738-130, A40738-131, A40738-132, A40738-133, A40738-134, A40738-135, A40738-136, A40738-137, A40738-138, A40738-139, A40738-140, A40738-141, A40738-142, A40738-143, A40738-144, A40738-145, A40738-146, A40738-147, A40738-148, A40738-149, A40738-150, A40738-151, A40738-152, A40738-153, A40738-154, A42221-086, A42221-087, A42221-088, A42221-089, A42221-090, A42221-091, A42221-092, A42221-093, A42221-094, A42221-095, A42221-096, A42221-097, A42221-098, A42221-099, A42221-100, A42221-101, A42221-102, A42221-103, A42221-104, A42221-105, A42221-106, A42221-107, A42221-108, A42221-109, A42221-110, A42221-111, A42221-112, A42221-113, A42221-114, A42221-115, A42221-116, A42221-117, A42221-118, A42221-119, A42221-120, A42221-121, A42221-122, A42221-123, A42221-124, A42221-125, A42221-126, A42221-127, A42221-128, A42221-129, A42221-130, A42221-131, A42221-132, A42221-133, A42221-134, A42221-135, A42221-136, A42221-137, A42221-138, A42221-139, A42221-140, A42221-141, A42221-142, A42221-143, A42221-144, A42221-145, A42221-146, A42221-147, A42221-148, A42221-149, A42221-150, A42221-151, A42221-152, A42221-153, A42221-154, A42221-155, A42221-156, A42221-157, A42221-158, A42221-159, A42221-160, A42221-161, A42221-162, A42221-163, A42221-164, A42221-165, A42221-166, A42221-167, A42221-168, A42221-169, A42221-170, A42221-171, A42221-172, A42221-173, A42221-174, A42221-175, A42221-176, A42221-177, A42221-178, A42221-179, A42221-180, A42221-181, A42221-182, A42221-183, A42221-184, A42221-185, A42221-186, A42221-187, A42221-188, A42221-189, A42221-190, A42221-191, A42221-192, A42545-014, A42545-015, A42545-016, A42545-017, A42545-018, A42545-019, A42545-020, A42545-021, A42545-022, A42545-023, A42545-024, A42545-026, A42545-027, A42545-028, A42545-029, A42545-030, A42545-031, A42545-032, A42545-033, A42545-034, A42545-035, A42545-036, A42545-037, A42545-038, A42545-039, A42545-040, A42545-041, A42545-042, A42545-043, A42545-044, A42545-045, A42545-046, A42545-047, A42545-048, A42545-049, A42545-050, A42545-051, A42545-052, A42545-053, A42545-054, A42545-055, A42545-056, A42545-057, A42545-058, A42545-059, A42545-060, A42545-061, A42545-062, A42545-063, A42545-064, A42545-065, A42545-066, A42545-067, A42545-068, A42545-069, A42545-070, A42545-071, A42545-072, A42545-073, A42545-074, A42545-075, A42545-076, A42545-077, A42545-078, A42545-079, A42545-080, A42545-081, A42545-082, A42545-083, A42545-084, A42545-085, A42545-086, A42545-087, A42545-088, A42545-089, A42545-090, A42545-091, A42545-092, A42545-093, A42545-094, A42545-095, 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A43231-123, A43231-124, A43231-125, A43231-126, A43336-040, A43336-041, A43336-042, A43336-043, A43336-044, A43336-045, A43336-046, A43336-047, A43336-048, A43336-049, A43336-050, A43336-051, A43336-052, A43336-053, A43336-054, A43336-055, A43336-056, A43336-057, A43336-058, A43336-059, A43336-060, A43336-061, A43336-062, A43336-063, A43336-064, A43336-065, A43336-066, A43336-067, A43336-068, A43336-069, A43336-070, A43336-071, A43336-072, A43336-073, A43336-074, A43336-075, A43336-076, A43336-077, A43336-078, A43336-079, A43336-080, A43336-081, A43336-082, A43336-083, A43336-084, A43336-085, A43336-086, A43336-087, A43336-088, A43336-089, A43336-090, A43336-091, A43336-092, A43336-093, A43336-094, A43336-095, A43336-096, A43336-097, A43336-098, A43336-099, A43336-100, A43336-101, A43336-102, A43336-103, A43336-104, A43336-105, A43336-106, A43336-107, A43336-108, A43336-109, A43336-110, A43336-111, A43336-112, A43336-113, A43336-114, A43336-115, A43336-116, A43336-117, A43344-248, A43344-249, A43344-250, A43344-251, A43344-252, A43344-253, A43344-254, A43344-255, A43344-256, A43344-257, A43344-258, A43344-259, A43344-260, A43344-261, A43344-262, A43344-263, A43344-264, A43344-265, A43344-266, A43344-267, A43344-268, A43344-269, A43344-270, A43344-271, A43344-272, A43344-273, A43344-274, A43344-275, A43344-276, A43344-277, A43344-278, A43344-279, A43344-280, A43344-281, A43344-282, A43344-283, A43344-284, A43344-285, A43344-286, A43344-287, A43344-288, A43344-289, A43344-290, A43344-291, A43344-292, A43344-293, A43344-294, A43344-295, A43344-296, A43344-297, A43344-298, A43344-299, A43344-300, A43344-301, A43344-302, A43344-303, A43344-304, A43344-305, A43344-306, A43344-308, A43344-309, A43344-310, A43344-311, A43344-312, A43344-313, A43344-314, A43344-315, A43344-316, A43344-317, A43345-096, A43345-097, A43345-098, A43345-099, A43345-100, A43345-101, A43345-102, A43345-103, A43345-104, A43345-105, A43345-106, A43345-107, A43345-108, A43345-109, A43345-110, A43345-111, A43345-112, A43345-113, A43345-114, A43345-115, A43345-116, A43345-117, A43345-118, A43345-119, A43345-120, A43345-121, A43345-122, A43345-123, A43345-124, A43345-125, A43345-126, A43345-127, A43345-128, A43345-129, A43345-130, A43345-131, A43345-132, A43345-133, A43345-134, A43345-135, A43345-136, A43345-137, A43345-138, A43345-139, A43345-140, A43345-141, A43345-142, A43345-143, A43345-144, A43345-145, A43345-146, A43345-147, A43345-148, A43345-149, A43345-150, A43345-151, A43345-152, A43345-153, A43345-154, A43345-155, A44405-011, A44405-012, A44405-013, A44405-014, A44405-015, A44405-016, A44405-017, A44405-018, A44405-019, A44405-020, A44405-021, A44405-022, A44405-023, A44405-024, A44405-025, A44405-026, A44405-027, A44405-028, A44405-029, A44405-030, A44405-031, A44405-032, A44405-033, A44405-034, A44405-035, A44405-036, A44405-037, A44405-038, A44405-039, A44405-040, A44405-041, A44405-042, A44405-043, A44405-044, A44405-045, A44405-046, A44405-047, A44405-048, A44405-049, A44405-050, A44405-051, A44405-052, A44405-053, A44405-054, A44413-051, A44413-052, A44413-053, A44413-054, A44413-055, A44413-056, A44413-059, A44413-060, A44413-061, A44413-062, A44413-063, A44413-064, A44413-065, A44413-066, A44413-067, A44413-068, A44413-069, A44413-070, A44413-071, A44413-072, A44413-073, A44413-074, A44413-075, A44413-076, A44413-077, A44413-078, A44413-079, A44413-080, A44413-081, A44413-082, A44413-083, A44413-084, A44413-085, A44413-086, A44413-087, A44413-088, A44413-089, A44413-090, A44413-091, A44413-092, A44413-093, A44413-094, A44413-095, A44413-097, A44413-098, A44413-099, A44413-100, A44413-101, A44413-102, A44413-103, A44413-104, A44413-105, A44413-106, A44413-108, A44413-109, A44413-110, A44413-111, A44413-112, A44413-113, A44413-114, A44413-115, A44413-116, A44413-117, A44413-118, A44413-119, A44413-120, A44413-121, A44413-122, A44413-123, A44413-124, A44413-125, A44413-126, A44413-127, A44413-128, A44413-129, A44413-130, A44413-131, 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Distribution pattern

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Brunei Darussalam, Canada, Chile, Colombia, Denmark, Dominican Republic, Ecuador, Finland, Ghana, Greece, Guatemala, Hong Kong, India, Ireland, Israel, Jamaica, Japan, Jordan, Korea, Republic Of, Kuwait, Lebanon, Liechtenstein, Luxembourg, Macao, Malaysia, Mexico, Mongolia, Namibia, Netherlands, New Zealand, Norway, Oman, Panama, Paraguay, Peru, Philippines, Portugal, Puerto Rico, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Taiwan, Thailand, Trinidad And Tobago, United Arab Emirates, United Kingdom, Viet Nam.

device · product 12 of 12

Medtronic XPANSE Bone Insert: a) DBM T600106 XPANSE SMALL-C 6, REF T600106; b) DBM T600206 XPANSE MEDIUM-C 6, REF T600206; c) DBM T600209 XPANSE MEDIUM-C 9, REF T600209; d) DBM T600306 XPANSE LARGE-C 6, REF T600306; e) DBM T600309 XPANSE LARGE-C 9, REF T600309; f) DBM T600612 XPANSE LARGE-L, REF T600612; Demineralized Bone Matrix (DBM) product

Z-1334-2023
Recall number
Z-1334-2023
Initiated
February 08, 2023
Classification
Class II
Status
Ongoing
Quantity
4348 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach in the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.

Code information

a) DBM T600106 XPANSE SMALL-C 6, REF T600106, GTIN 00643169218314, Serial Numbers: A41747-061, A41747-062, A41747-063, A41747-064, A41747-065, A41747-066, A41747-067, A41747-068, A41747-069, A41747-070, A41747-071, A41747-072, A41747-073, A43745-061, A43745-062, A43745-063, A43745-064, A43745-065, A43745-066, A43745-067, A43745-068, A43745-069, A43745-070, A43745-071, A43745-072, A43745-073, A43745-074, A43745-075, A43748-036, A43748-037, A43748-038, A43748-039, A43748-040, A46458-036, A46458-037, A46458-038, A46458-039, A46458-040, A46458-041, A46458-042, A46458-043, A46458-044, A46458-045, A46458-046, A46458-047, A46458-048, A49576-028, A49576-029, A49576-030, A49576-031, A49576-032, A49576-033, A49576-034, A49576-035, A49576-036, A49576-037, A49576-038, A49576-039, A49576-040; b) DBM T600206 XPANSE MEDIUM-C 6, REF T600206, GTIN 00643169218352, Serial Numbers: A38618-078, A38618-079, A38618-080, A38618-081, A38618-082, A38618-083, A38618-084, A38618-085, A38618-086, A38618-087, 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A52340-092, A52340-093, A52340-094, A52340-095, A52340-096, A52340-097, A52340-098, A53036-073, A53036-074, A53036-075, A53036-076, A53036-078, A53036-079, A53036-080, A53036-081, A53036-082, A53036-083, A53036-084, A53036-085, A53036-086, A53036-087, A53036-088, A53036-089, A53036-090, A53036-091, A53036-095, A53036-096, A53036-097, A53036-098, A53036-099, A53036-100, A53036-101, A53036-102, A53036-103, A53036-104, A53036-105, A53036-106, A53036-107, A53036-108, A53036-109, A53036-110, A53036-111, A53036-112, A53036-113, A53036-114, A53036-115, A53036-116, A53036-117, A53036-118, A53036-119, A53036-120, A53036-121, A53036-122, A53036-123, A53036-124, A53036-125, A53036-126, A53036-127, A53036-128, A53036-129, A53036-130, A53036-131, A53036-132, A53036-133, A53036-134, A53036-135, A53036-136, A53036-138, A53036-139, A53036-140, A53036-141, A53036-142, A53036-143, A53036-144, A53036-145; c) DBM T600209 XPANSE MEDIUM-C 9, REF T600209, GTIN 00643169218376, Serial Numbers: A40169-098, A40169-099, A40169-100, A40169-101, A40169-102, A40169-103, A40169-104, A40169-105, A40169-106, A40169-107, A40169-108, A40169-109, A40169-110, A40169-111, A40169-112, A40169-113, A40169-114, A40169-115, A40169-116, A40169-117, A40169-118, A40169-119, A40169-120, A40169-121, A40169-122, A40169-123, A40169-124, A40169-125, A40169-126, A40169-127, A40169-128, A40169-129, A40169-130, A40169-131, A40169-132, A40169-133, A40169-134, A40169-135, A40169-136, A40169-137, A40169-138, A40169-139, A40169-140, A40169-141, A40169-142, A40734-040, A40734-041, A40734-042, A40734-043, A40734-044, A40734-045, A40734-046, A40734-047, A40734-048, A40734-049, A40734-050, A40734-051, A40734-052, A40734-053, A40734-054, A40734-055, A40734-056, A41315-130, A41315-131, A41315-132, A41315-133, A41315-134, A41315-135, A41315-137, A41315-138, A41315-139, A41315-140, A41315-141, A41315-142, A41315-143, A41315-144, A41315-145, A41315-146, A41315-147, A41315-148, A41315-149, A41315-150, A41315-151, A41315-152, A41315-153, A41315-154, A41315-155, A41315-156, A41315-157, A41315-158, A41315-159, A41315-160, A41315-161, A41315-162, A41315-163, A41315-164, A41315-165, A41315-166, A41315-167, A41315-168, A41315-169, A41479-108, A41479-109, A41479-110, A41479-111, A41479-112, A41479-113, A41479-114, A41479-115, A41479-116, A41479-117, A41479-118, A41479-119, A41479-120, A41479-121, A41479-122, A41479-123, A41479-124, A41479-125, A41479-126, A41479-127, A41479-128, A41479-129, A41479-130, A41479-131, A41479-132, A41479-133, A41479-134, A41479-135, A41479-136, A41479-137, A41479-138, A41479-139, A41479-140, A41479-141, A41479-142, A41479-143, A41479-144, A41479-145, A41479-146, A41479-147, A41479-148, A41479-149, A41479-150, A41479-151, A41479-152, A41479-153, A41479-154, A41479-155, A41479-156, A41479-157, A41479-158, A41479-159, A41479-160, A41479-161, A41479-162, A41479-163, A41479-164, A41479-165, A41479-166, A41479-167, A42964-112, A42964-113, A42964-114, A42964-115, A42964-116, A42964-117, A42964-118, A42964-120, A42964-121, A42964-122, A42964-123, A42964-124, A42964-125, A42964-126, A42964-127, A42964-128, A42964-129, A42964-130, A42964-131, A42964-132, A42964-133, A42964-134, A42964-135, A42964-136, A42964-137, A42964-138, A42964-139, A42964-140, A42964-141, A42964-142, A42964-143, A42964-144, A42964-145, A42964-146, A42964-147, A42964-148, A42964-149, A42964-150, A42964-151, A42964-152, A42964-153, A42964-154, A42964-155, A42964-156, A42964-157, A42964-158, A42964-159, A42964-160, A42964-161, A42964-162, A43287-081, A43287-082, A43287-083, A43287-084, A43287-085, A43287-086, A43287-087, A43287-088, A43287-089, A43287-090, A43287-091, A43287-092, A43287-093, A43287-094, A43287-095, A43287-096, A43299-085, A43299-086, A43299-087, A43299-088, A43299-089, A43299-090, A43299-091, A43299-092, A43299-093, A43299-094, A43299-095, A43299-096, A43299-097, A43299-098, A43299-099, A43299-100, A43299-101, A43299-102, A43299-103, A43299-104, A43299-105, A43299-106, A43299-107, A43299-108, A43299-109, A43299-110, A43299-111, A43299-112, A43299-113, A43748-136, A43748-137, A43748-138, A43748-139, A43748-140, A43748-141, A43748-142, A43748-143, A43748-144, A43748-145, A43748-146, A43748-147, A43748-148, A43748-149, A43748-150, A43748-151, A43748-152, A43748-153, A43748-154, A43748-155, A43748-156, A43748-157, A43748-158, A43748-159, A43748-160, A43748-161, A43748-162, A43748-163, A43748-164, A43748-165, A43748-166, A43748-167, A43748-168, A43748-169, A43748-170, A43748-172, A43748-173, A43748-174, A43748-175, A43748-176, A43748-177, A43748-178, A43748-179, A43748-180, A43748-181, A43748-184, A43748-186, A43748-187, A43748-188, A43748-189, A43748-190, A43748-193, A43748-195, A43748-198, A43748-199, A43748-200, A43748-201, A43748-202, A43748-203, A43748-204, A43748-205, A43748-206, A43748-207, A43748-208, A43748-209, A43748-210, A43748-211, A43748-212, A45739-192, A45739-193, A45739-194, A45739-195, A45739-196, A46844-092, A46844-093, A46844-094, A46844-095, A46844-096, A46844-097, A46844-098, A46844-099, A46844-100, A46844-101, A46844-102, A46844-103, A46844-104, A46844-105, A46844-106, A46844-107, A46844-108, A46844-109, A46844-110, A46844-111, A46844-112, A46844-113, A46844-114, A46844-115, A46844-116, A46844-117, A46844-118, A46844-119, A46844-120, A47673-101, A47673-102, A47673-103, A47673-104, A47673-107, A47673-108, A47673-109, A47673-110, A47673-111, A47673-112, A47673-113, A47673-114, A47673-115, A47673-116, A47673-117, A47673-118, A47673-119, A47673-120, A47673-121, A47673-122, A47673-123, A47673-124, A47673-125, A47673-126, A47673-127, A47673-128, A47673-129, A47673-130, A47673-131, A47673-132, A47673-133, A47673-134, A47673-135, A47673-136, A47673-137, A47673-138, A47673-139, A47673-140, A47673-141, A47673-142, A47673-143, A47673-144, A47673-145, A47673-146, A47673-147, A47673-148, A47673-149, A47673-150, A47673-151, A47673-152, A47673-153, A47673-154, A47673-155, A47673-156, A47673-157, A47673-158, A47673-159, A47673-160, A47673-161, A47673-162, A47673-163, A47673-164, A47673-165, A47673-166, A47673-167, A47673-168, A47673-169, A47673-170, A47673-171, A47673-172, A47728-060, A47728-061, A47728-062, A47728-063, A47728-064, A47728-065, A47728-066, A47728-067, A47728-068, A47728-069, A47728-070, A47728-071, A47728-072, A47728-073, A47728-074, A47728-075, A47728-076, A47728-077, A47728-078, A47728-079, A47728-080, A47728-081, A47728-082, A47728-083, A47728-084, A47728-085, A47728-086, A47728-087, A47728-088, A47728-089, A47728-090, A47728-091, A47728-092, A47728-093, A47728-094, A47728-095, A47728-096, A47728-097, A47728-098, A47728-099, A49576-101, A49576-102, A49576-103, A49576-104, A49576-105, A49576-106, A49576-107, A49576-108, A49576-109, A49576-110, A49576-111, A49576-112, A49576-113, A49576-114, A49576-115, A49576-116, A49576-117, A49576-118, A49576-119, A49576-120, A49576-121, A49576-122, A49576-124, A49576-125, A49576-126, A49576-127, A49576-128, A49576-129, A49576-130, A49576-132, A49576-133, A49576-134, A49576-135, A49576-136, A49579-071, A49579-072, A49579-073, A49579-074, A49579-075, A49579-076, A49579-077, A49579-078, A49579-079, A49579-080, A49579-081, A49579-082, A49579-083, A49579-084, A49579-085, A49579-086, A49579-087, A49579-089, A49579-090, A49579-091, A49579-092, A49579-093, A49579-094, A49579-095, A49579-096, A49579-097, A49579-098, A49579-099, A49579-100, A49752-023, A49752-024, A49752-025, A49752-026, A49752-027, A49752-028, A49752-029, A49752-030, A49752-031, A49752-032, A49752-033, A49752-034, A49752-035, A49752-036, A49752-037, A49752-038, A49752-039, A49752-040, A49752-041, A49752-042, A49752-043, A49752-044, A49752-045, A49752-046, A49752-047, A49752-048, A49752-049, A49752-050, A49752-051, A51605-097, A51605-098, A51605-099, A51605-100, A51605-101, A51605-102, A51605-103, A51605-104, A51605-105, A51605-106, A51605-107, A51605-108, A51605-109, A51605-110, A51605-111, A51605-112, A51605-113, A51605-114, A51605-115, A51605-116, A51605-117, A51605-118, A51605-120, A51605-121, A51605-122, A51605-123, A51605-124, A51605-125, A51605-126, A51605-127, A51605-128, A51605-129, A51605-130, A51605-131, A51605-132, A51605-133, A51605-134, A51605-135, A51605-136, A51605-137, A51605-138, A51605-139, A51605-140, A51605-141, A51605-142, A51605-143, A51605-144, A51605-145, A51605-146, A51605-147, A51605-148, A51605-149, A51605-150, A51605-151, A51605-152, A51605-153, A51605-154, A51605-155, A51605-156, A52340-099, A52340-100, A52340-101, A52340-102, A52340-104, A52340-106, A52340-109, A52340-112, A52340-113, A52340-115, A52340-116, A52340-119, A52340-134, A52340-135, A52340-136, A52340-138, A52340-140, A52340-141, A52340-142, A52340-143, A52340-144, A52340-145, A52340-146, A52340-147, A52340-148, A52340-149, A52340-155, A52340-156, A52340-157, A52340-158, A52340-159, A52340-160, A52340-161, A52340-162, A52340-163, A52340-164, A52340-165, A52340-166, A52340-167, A52340-168, A52340-169, A53036-146, A53036-147; d) DBM T600306 XPANSE LARGE-C 6, REF T600306, GTIN 00643169218390, Serial Numbers: A38618-018, A38618-019, A38618-020, A38618-021, A38618-022, A38618-023, A38618-024, A38618-025, A38618-026, A38618-027, A38618-028, A38618-029, A38618-030, A38618-031, A38618-032, A38618-033, A38618-034, A38618-035, A38618-036, A38618-037, A38618-038, A38618-039, A38618-040, A38618-041, A38618-042, A38618-043, A38618-044, A38618-045, A38618-046, A38618-047, A38618-048, A38618-049, A38618-050, A38618-051, A38618-052, A38618-053, A38618-054, A38618-055, A38618-056, A38618-057, A38618-058, A38618-059, A38618-060, A38618-061, A38618-062, A38618-063, A38618-064, A38618-065, A38618-066, A38618-067, A38618-068, A38618-069, A38618-070, A38618-071, A38618-072, A38618-073, A38618-074, A38618-075, A38618-076, A38618-077, A39566-113, A39566-114, A39566-115, A39566-116, A39566-117, A39566-118, A39566-119, A39566-120, A39566-121, A39566-122, A39566-123, A39566-124, A39566-125, A39566-126, A39566-127, A39566-128, A39566-129, A39566-130, A39566-131, A39566-132, A39566-133, A39566-134, A39566-135, A39566-136, A39566-137, A39566-138, A39566-139, A39566-140, A39566-141, A39566-142, A39566-143, A39566-144, A39566-145, A39566-146, A39566-147, A39566-148, A39566-149, A39566-150, A39566-151, A39566-152, A39566-153, A39566-154, A39566-155, A39566-156, A39566-157, A39566-158, A39566-159, A39566-160, A39566-161, A39566-162, A39566-163, A39566-164, A39566-165, A39566-166, A39566-167, A39566-168, A39566-169, A39566-170, A39566-171, A39566-172, A39566-173, A39566-174, A39566-175, A39566-176, A39566-177, A39566-178, A39566-179, A39566-180, A39566-181, A39566-182, A39566-183, A39566-184, A39566-185, A39566-186, A40105-083, A40105-084, A40105-085, A40105-086, A40105-087, A40105-088, A40105-089, A40105-090, A40105-091, A40105-092, A40105-093, A40105-094, A40105-095, A40105-096, A40105-097, A40105-098, A40105-099, A40105-100, A40105-101, A40105-102, A40105-103, A40105-104, A40105-105, A40105-106, A40105-107, A40105-108, A40105-109, A40105-110, A40105-111, A40105-112, A40105-113, A40105-114, A40105-115, A40105-116, A40105-117, A40105-118, A40105-119, A40105-120, A40105-121, A40105-122, A40105-123, A40105-124, A40105-125, A40105-126, A40105-127, A40105-128, A40105-129, A40105-130, A40105-131, A40169-149, A40169-150, A40169-151, A40169-152, A40169-153, A40169-154, A40169-155, A40169-156, A40169-157, A40169-158, A40169-159, A40169-160, A40169-161, A40169-162, A40169-163, A40169-164, A40169-165, A40169-166, A40169-167, A40169-168, A40169-169, A40169-170, A40169-171, A40169-172, A40169-173, A40169-174, A40169-175, A40169-176, A40169-177, A40169-178, A40169-179, A40169-180, A40169-181, A40169-182, A40169-183, A40169-184, A40169-185, A40169-186, A40169-187, A40169-188, A40169-189, A40169-190, A40169-191, A40734-057, A40734-058, A40734-059, A40734-060, A40734-061, A40734-062, A40734-063, A40734-064, A40734-065, A40734-066, A40734-067, A40734-068, A40734-069, A40734-070, A40734-071, A40734-072, A40734-073, A40734-074, A40734-075, A40734-076, A40734-077, A40734-078, A40734-079, A40734-080, A40734-081, A40734-082, A40734-083, A40734-084, A40734-085, A40734-086, A40734-087, A40734-088, A40734-089, A40734-090, A40734-091, A40734-092, A40734-093, A40734-094, A40734-095, A40734-096, A40734-097, A40734-098, A40734-099, A40734-100, A40734-101, A40734-102, A40734-103, A40734-104, A40734-105, A40734-106, A40734-107, A40734-108, A40734-109, A40734-110, A40734-111, A40734-112, A40734-113, A40734-114, A40734-115, A40734-116, A40734-117, A40734-118, A40734-119, A40734-120, A40734-121, A40734-122, A40734-123, A40734-124, A40734-125, A40734-126, A40734-127, A40734-128, A40734-129, A41315-170, A41315-171, A41315-172, A41315-173, A41315-174, A41315-175, A41315-176, A41315-177, A41315-178, A41315-179, A41315-180, A41315-181, A41315-182, A41315-183, A41315-184, A41315-185, A41315-186, A41315-187, A41315-188, A41315-189, A41315-190, A41315-191, A41315-192, A41315-193, A41315-194, A41315-195, A41315-196, A41315-197, A41393-026, A41393-027, A41393-028, A41393-029, A41393-030, A41393-031, A41393-032, A41393-033, A41393-034, A41393-035, A41393-036, A41393-037, A41393-038, A41393-039, A41393-040, A41393-041, A41393-042, A41393-043, A41393-044, A41393-045, A41393-046, A41393-047, A41393-048, A41393-049, A41393-050, A41393-051, A41393-052, A41393-053, A41393-054, A41393-055, A41393-056, A41393-057, A41393-058, A41393-059, A41393-060, A41393-061, A41393-062, A41393-063, A41393-064, A41393-065, A41393-066, A41393-067, A41393-068, A41393-069, A41393-070, A41393-071, A41393-072, A41393-073, A41393-074, A41393-075, A41393-076, A41393-077, A41393-078, A41393-079, A41393-080, A41393-081, A41393-082, A41393-083, A41393-084, A41393-085, A41479-168, A41479-169, A41479-170, A41479-171, A41479-172, A41479-173, A41479-174, A41479-175, A41479-176, A41479-177, A41479-178, A41479-179, A41479-180, A41479-181, A41479-182, A41479-183, A41479-184, A41479-185, A41479-186, A41479-187, A41479-188, A41479-189, A41479-190, A41479-191, A41479-192, A41479-193, A41479-194, A41479-195, A41479-196, A41479-197, A41479-198, A41479-199, A41479-200, A41479-201, A41479-202, A41479-203, A41479-204, A41479-205, A41479-206, A41747-121, A41747-122, A41747-123, A41747-124, A41747-125, A41747-126, A41747-127, A41747-128, A41747-129, A41747-130, A41747-131, A41747-132, A41747-133, A41747-134, A41747-135, A41747-136, A41747-137, A41747-138, A41747-139, A41747-140, A41747-141, A41747-142, A41747-143, A41747-144, A41747-145, A41747-146, A41747-147, A41747-148, A41747-149, A41747-150, A41747-151, A41747-152, A41747-153, A41747-154, A41747-155, A41747-156, A41747-157, A41747-158, A41747-159, A41747-160, A41747-161, A41747-162, A41747-163, A41747-164, A41747-165,

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Brunei Darussalam, Canada, Chile, Colombia, Denmark, Dominican Republic, Ecuador, Finland, Ghana, Greece, Guatemala, Hong Kong, India, Ireland, Israel, Jamaica, Japan, Jordan, Korea, Republic Of, Kuwait, Lebanon, Liechtenstein, Luxembourg, Macao, Malaysia, Mexico, Mongolia, Namibia, Netherlands, New Zealand, Norway, Oman, Panama, Paraguay, Peru, Philippines, Portugal, Puerto Rico, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Taiwan, Thailand, Trinidad And Tobago, United Arab Emirates, United Kingdom, Viet Nam.