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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93163

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

Open FDA event record

Event summary

Timeline bucket
September 26, 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

7 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 7

Grafton DBM Crunch, Model Numbers: T44115, Demineralized Bone Matrix

Z-0161-2024
Recall number
Z-0161-2024
Initiated
September 26, 2023
Classification
Class II
Status
Ongoing
Quantity
84 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch.

Code information

GTIN 00643169123113, Serial Numbers: A59083-054, A59083-055, A59083-056, A59083-057, A59083-058, A59083-059, A59083-060, A59083-061, A59083-062, A59083-063, A59083-064, A56737-049, A56737-050, A56737-051, A56737-052, A56737-053, A56737-054, A56737-055, A56737-056, A56737-057, A56737-058, A56737-059, A56737-060, A56737-061, A56737-062, A56737-063, A56858-021, A56858-022, A56858-023, A56858-024, A56858-025, A56858-026, A56858-027, A56858-028, A56858-029, A56858-030, A56858-031, A56858-032, A56858-033, A56858-034, A56858-035, A56858-036, A57174-060, A57174-061, A57174-062, A57174-063, A57174-064, A57174-065, A57174-066, A57174-067, A57174-068, A57174-069, A57174-070, A57174-071, A57617-066, A57617-067, A57617-068, A57617-069, A57617-070, A57617-071, A57617-072, A57617-073, A57617-074, A57617-075, A57617-076, A57617-077, A57617-078, A58281-035, A58281-036, A58281-037, A58281-038, A58281-039, A58281-040, A58281-041, A58281-042, A58281-043, A58281-044, A58281-045, A58281-046, A58281-047, A59083-050, A59083-051, A59083-052, A59083-053

Distribution pattern

US, Colombia, S. Korea, New Zealand, India, Taiwan

device · product 2 of 7

Grafton DBM (Flex), Model Numbers: T42100, Demineralized Bone Matrix

Z-0162-2024
Recall number
Z-0162-2024
Initiated
September 26, 2023
Classification
Class II
Status
Ongoing
Quantity
77 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch.

Code information

GTIN 00643169123007, Serial Numbers: A57164-040, A58820-011, A57164-041, A57164-042, A59190-046, A59190-041, A59190-042, A59190-043, A59190-044, A59190-045, A57164-026, A57164-027, A57164-028, A57164-029, A57164-030, A57164-031, A57164-032, A57164-033, A58820-017, A58820-018, A57164-011, A57164-012, A57164-013, A57164-014, A57164-015, A57164-016, A57164-017, A57164-018, A57164-019, A57164-020, A57164-021, A57164-022, A57164-023, A57164-024, A57164-025, A57164-034, A57164-035, A57164-036, A57164-037, A57164-038, A57164-039, A58820-012, A58820-013, A58820-014, A58820-015, A58820-016, A58820-019, A58820-020, A58820-021, A58820-022, A58820-023, A58820-024, A58820-025, A58820-026, A58820-027, A58820-028, A58820-029, A58820-030, A58820-031, A58820-033, A58820-034, A58820-035, A58820-036, A58820-037, A58820-038, A58820-039, A58820-040, A59190-031, A59190-032, A59190-033, A59190-034, A59190-035, A59190-036, A59190-037, A59190-038, A59190-039, A59190-040

Distribution pattern

US, Colombia, S. Korea, New Zealand, India, Taiwan

device · product 3 of 7

Grafton DMB Matrix, Model Numbers: a) T42200, b) T42210; Demineralized Bone Matrix

Z-0163-2024
Recall number
Z-0163-2024
Initiated
September 26, 2023
Classification
Class II
Status
Ongoing
Quantity
377 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch.

Code information

a) T42200: GTIN 00643169123052, Serial Numbers: A59254-013, A57871-018, A59117-013, A59254-018, A59264-016, A58526-014, A58526-015, A58526-016, A58864-018, A58082-016, A58983-011, A58983-012, A59320-013, A59320-016, A57043-011, A58831-018, A59307-012, A59320-019, A58831-019, A59117-020, A57104-018, A58408-015, A58408-016, A58952-019, A59307-011, A59264-014, A58526-011, A58526-012, A58408-011, A58995-025, A59140-014, A59140-015, A59165-012, A56808-011, A56808-012, A57078-011, A57078-012, A58077-013, A59117-021, A59264-015, A57871-014, A56808-019, A56808-020, A57078-013, A57078-014, A57078-015, A57078-016, A57078-017, A58649-011, A58649-012, A58649-013, A58649-014, A58649-015, A58649-016, A58649-017, A58983-018, A58983-019, A58983-020, A59117-011, A59117-015, A58983-017, A58995-026, A56808-013, A58408-012, A57104-011, A58077-014, A59165-013, A59165-014, A58864-012, A56808-016, A56808-017, A57043-019, A57104-012, A57104-013, A57104-014, A57104-015, A58701-011, A58701-012, A58701-013, A58701-014, A58701-015, A58701-016, A58864-011, A58952-011, A58952-012, A58864-013, A58864-014, A58864-015, A58526-017, A59243-014, A58831-011, A58077-015, A58077-016, A58077-017, A58605-011, A58526-013, A59254-017, A57871-015, A57871-016, A58082-011, A59165-020, A59264-017, A59264-018, A56808-014, A58831-012, A59243-013, A59243-016, A59243-017, A59254-014, A59254-016, A59320-014, A58605-012, A58605-013, A58605-014, A58605-015, A57043-015, A58983-013, A58649-018, A58864-016, A58864-017, A59140-013, A59140-017, A59140-019, A59140-020, A59254-015, A59320-020, A59320-021, A57043-012, A58831-013, A58831-014, A56808-015, A57104-016, A58983-014, A58983-015, A58983-016, A59117-014, A59117-016, A59117-017, A57871-013, A58082-012, A58952-015, A59140-018, A59264-013, A58831-015, A58831-016, A58831-017, A58859-011, A57043-016, A58831-020, A58859-012, A58859-013, A58859-014, A59264-019, A59264-020, A59320-011, A59320-012, A59243-015, A59307-013, A59320-017, A59320-018, A58082-015, A58859-015, A59307-014, A59307-015, A58082-019, A58082-020, A58952-020, A59254-011, A57043-013, A58408-014, A59117-018, A59117-019, A58841-015, A58841-016, A58841-017, A58841-018, A59165-015, A59165-016, A59165-017, A59165-018, A57043-017, A57043-018, A58082-013, A58408-013, A59140-011, A59140-012, A57043-014, A58952-013, A58952-014, A58077-011, A58082-014, A59165-019, A57871-011, A57871-012, A58082-017, A58082-018, A59264-011, A59264-012, A58077-012, A59165-011, A58859-016, A58859-017, A57104-017, A58859-018, A56808-018, A57871-017, A58408-017, A59140-016, A58841-014, A58952-016, A59117-012, A59243-018, A59320-015, A59254-012; b) T42210: GTIN 00643169123069, Serial Numbers: A58133-043, A59122-023, A58133-046, A58518-019, A58518-020, A57362-017, A57362-019, A58545-022, A58133-045, A57362-011, A58545-028, A59122-022, A57344-020, A59122-017, A57344-021, A58133-044, A59122-018, A57344-022, A57344-018, A57344-019, A58545-024, A58518-015, A58545-011, A58545-012, A58133-047, A58518-011, A58518-012, A58518-013, A58518-014, A58122-011, A58122-012, A58122-013, A58122-014, A58122-015, A58122-016, A58122-017, A58122-018, A57344-023, A58518-016, A57387-026, A57387-027, A58518-017, A58518-018, A58545-013, A58545-014, A57387-029, A58518-031, A57344-024, A57387-011, A57387-012, A57387-013, A57387-014, A57387-015, A59122-019, A59122-020, A59122-021, A59122-024, A58518-021, A58518-022, A58518-023, A58518-024, A58518-025, A59200-013, A57362-012, A57362-013, A59200-014, A59200-015, A58545-016, A58545-023, A57387-024, A58545-015, A59122-025, A59122-026, A59122-027, A59200-011, A59200-012, A57344-013, A57344-025, A58545-017, A58545-018, A57344-017, A58133-041, A58133-042, A57387-016, A57387-017, A59200-016, A59200-017, A59200-018, A59200-019, A59200-020, A59200-021, A59200-022, A57387-028, A58133-036, A58133-040, A58545-029, A57362-014, A57362-015, A57362-016, A57387-018, A57387-019, A57387-020, A57387-021, A57387-022, A57387-023, A58122-019, A58122-020, A58122-021, A58122-022, A58122-023, A58133-039, A57362-018, A58518-032, A58518-033, A58518-034, A58133-031, A58518-028, A59200-023, A59200-024, A57362-020, A57362-021, A57362-022, A58122-024, A58122-025, A58518-026, A58545-021, A59200-025, A59200-026, A58545-019, A58545-020, A58133-032, A58133-033, A58133-035, A58518-027, A59200-027, A58133-034, A59122-014, A57344-011, A57344-012, A57344-014, A57344-015, A57344-016, A59200-028, A58545-025, A58545-026, A58545-027, A58518-030, A58133-037, A58133-038, A58518-029, A59122-015, A59122-016, A57387-025, A57362-023, A57362-024, A57362-025, A58122-026, A58122-027, A58122-028, A58122-029, A59122-011, A59122-012, A59122-013

Distribution pattern

US, Colombia, S. Korea, New Zealand, India, Taiwan

device · product 4 of 7

Grafton DBM Matrix Strips, Model Numbers: a) T42275, b) T42280; Demineralized Bone Matrix

Z-0164-2024
Recall number
Z-0164-2024
Initiated
September 26, 2023
Classification
Class II
Status
Ongoing
Quantity
282 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch.

Code information

a) T42275: GTIN 00643169123076, Serial Numbers: A58988-042, A58156-043, A59160-040, A59343-027, A58156-049, A58988-029, A58821-051, A58156-050, A59343-029, A59343-030, A59343-031, A59343-032, A59343-033, A59269-016, A59154-026, A59343-043, A59160-046, A59154-038, A59154-039, A59154-040, A59154-041, A59154-042, A58821-048, A58821-049, A59343-020, A59343-021, A59343-024, A59343-025, A59343-026, A58821-056, A58821-057, A58988-040, A59154-031, A59160-044, A58988-018, A58821-026, A58821-027, A58821-028, A58821-029, A58821-030, A58988-019, A58988-020, A58988-021, A59119-027, A58156-042, A58821-053, A58821-054, A58821-055, A58988-043, A58988-044, A58988-045, A59119-011, A59119-012, A59119-013, A59119-014, A59119-015, A59119-016, A59119-017, A59119-032, A59119-033, A59119-034, A59154-014, A59154-015, A59154-016, A59160-018, A59160-019, A59343-011, A59343-012, A59343-013, A59160-035, A59160-036, A59160-037, A58821-021, A58821-022, A58988-022, A58988-023, A58821-031, A58821-032, A58988-024, A59343-014, A59343-015, A58821-024, A58821-025, A59119-030, A59119-031, A58988-025, A58988-026, A58988-027, A58988-028, A59160-016, A59160-029, A59160-030, A59160-031, A59160-032, A59343-016, A59343-017, A59343-018, A58821-033, A59119-018, A59154-043, A59154-044, A59160-033, A59160-042, A59160-043, A58988-030, A58821-050, A59119-019, A59119-020, A59119-021, A59119-022, A59119-023, A59119-024, A59119-025, A59154-025, A59160-041, A59160-048, A59160-049, A58821-052, A58988-041, A59154-018, A59154-024, A59160-020, A59343-028, A58988-011, A58988-012, A59160-012, A59160-013, A59160-015, A58156-032, A58156-035, A58821-034, A58821-035, A58821-036, A59154-017, A59160-024, A59160-034, A59269-018, A58821-037, A58821-038, A58988-031, A58988-032, A58988-033, A58988-034, A58821-039, A58821-040, A59154-030, A58156-051, A59119-028, A59119-029, A59160-047, A59269-017, A58821-041, A58821-023, A58988-013, A58988-014, A58988-015, A59119-026, A59154-034, A59154-045, A59154-046, A59160-011, A59343-019, A58988-035, A59160-017, A58821-042, A58988-037, A59343-034, A58156-052, A59154-033, A59269-012, A59269-013, A59269-014, A59269-015, A58156-045, A58156-046, A58156-047, A58156-048, A59343-035, A59160-025, A59269-011, A59343-036, A59343-037, A58988-036, A59160-023, A59160-026, A59154-036, A59154-037, A59160-039, A59343-022, A59343-023, A58821-043, A58821-044, A58821-045, A58821-046, A58821-047, A58988-038, A58988-039, A59154-047, A59154-048, A59160-021, A59160-022, A59160-027, A59160-028, A59160-038, A59160-045, A59343-038, A59343-039, A59343-040, A59343-041, A59343-042, A58988-016, A58988-017; b) T42280, GTIN 00643169123083, Serial Numbers: A58840-084, A58489-021, A57660-021, A58489-023, A58489-024, A58812-035, A58812-038, A58582-011, A58264-023, A58264-024, A58264-025, A58264-011, A58264-012, A58489-017, A58489-018, A58840-087, A58489-011, A58085-011, A58840-091, A58812-031, A58840-088, A58840-086, A58812-041, A58812-042, A58812-032, A58812-033, A58812-034, A58840-080, A57660-011, A57660-012, A57660-013, A57660-014, A57660-017, A57660-018, A58264-013, A58812-045, A58840-076, A58840-077, A58840-078, A57660-019, A57660-020, A58840-082, A58489-022, A57660-015, A57660-016, A58812-039, A58840-079, A58840-085, A58264-014, A58489-020, A58812-037, A58812-043, A58812-044, A58840-081, A58840-083, A58812-040, A58489-019, A58812-036, A58840-089, A58264-015, A58264-016, A58264-017, A58264-018, A58264-019, A58264-020, A58489-012, A58489-013, A58489-014, A58264-021, A58264-022

Distribution pattern

US, Colombia, S. Korea, New Zealand, India, Taiwan

device · product 5 of 7

Grafton DBM Orthoblend, Model Numbers: a) T44125INT, b) T44135, c) T44145, d) T44150; Demineralized Bone Matrix

Z-0165-2024
Recall number
Z-0165-2024
Initiated
September 26, 2023
Classification
Class II
Status
Ongoing
Quantity
430 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch.

Code information

a) T44125INT: GTIN 00643169965058, Serial Numbers: A52559-042, A52559-024, A52559-038, A52559-039, A52559-040, A52559-041, A52559-044, A52559-045, A52559-021, A52559-022, A52559-023, A52559-025, A52559-026, A52559-027, A52559-028, A52559-029, A52559-030, A52559-031, A52559-032, A52559-033, A52559-034, A52559-035, A52559-036, A52559-037, A52559-043; b) T44135: GTIN 00643169122918, Serial Numbers: A59102-034, A59102-035, A58789-025, A58789-026, A58789-027, A59080-036, A59080-037, A58789-030, A58789-031, A58789-032, A58789-033, A58789-034, A58789-035, A58789-036, A58789-037, A58789-038, A58789-039, A59102-042, A59102-043, A59102-044, A59102-045, A59102-046, A59102-047, A59102-048, A59102-049, A59102-050, A59102-051, A59103-030, A59103-031, A59103-032, A59103-033, A59103-034, A59103-035, A59103-036, A59103-037, A59103-038, A59103-039, A59102-055, A59102-056, A58789-061, A58789-062, A59080-022, A59080-026, A59080-027, A59080-028, A59080-029, A59080-030, A59102-038, A59102-039, A59102-040, A59102-041, A59102-059, A59102-060, A59102-061, A59102-062, A58789-047, A59103-042, A59103-043, A59103-044, A59103-045, A59103-046, A58789-028, A58789-029, A59080-020, A59080-021, A59080-023, A59102-031, A59102-032, A59102-033, A59080-024, A59080-025, A59102-029, A59103-040, A59080-031, A59080-016, A59080-017, A58789-042, A58789-043, A58789-044, A58789-045, A58789-046, A58789-048, A58789-049, A58789-021, A58789-022, A58789-023, A59080-019, A59102-057, A59102-058, A59103-041, A58789-050, A58789-054, A58789-055, A58789-056, A58789-057, A58789-058, A58789-059, A58789-060, A59103-016, A59103-017, A59103-018, A59103-029, A59080-018, A59102-028, A59102-030, A59102-052, A59102-053, A59102-054; c) T44145: GTIN 00643169122925, Serial Numbers: A56911-076, A56911-070, A56911-071, A56911-023, A56911-067, A47028-065, A56911-082, A59197-041, A59197-059, A56911-074, A56911-075, A47028-053, A57248-034, A56911-018, A59197-057, A59197-036, A59197-037, A59197-020, A59197-021, A59197-022, A59197-023, A59197-024, A56911-028, A56911-029, A56911-030, A56911-031, A56911-033, A57248-039, A56911-034, A56911-035, A56911-080, A59197-034, A56911-077, A56911-078, A56911-079, A59197-047, A59197-044, A56911-068, A56911-044, A56911-045, A56911-046, A56911-081, A57248-020, A57248-032, A57248-036, A59197-062, A56911-032, A59197-055, A59197-051, A59197-052, A57248-025, A57248-026, A57248-027, A57248-028, A57248-029, A56911-041, A59197-048, A56911-020, A56911-024, A56911-025, A56911-047, A56911-048, A56911-049, A56911-050, A56911-051, A56911-052, A56911-053, A56911-054, A56911-055, A56911-056, A56911-057, A56911-058, A56911-042, A56911-043, A56911-072, A56911-073, A57248-013, A57248-014, A47028-036, A47028-037, A47028-038, A56911-059, A47028-039, A56911-027, A47028-040, A59197-011, A59197-012, A59197-013, A47028-059, A57248-033, A59197-018, A59197-019, A47028-066, A47028-067, A59197-049, A59197-050, A47028-041, A47028-042, A59197-040, A47028-043, A47028-044, A57248-011, A57248-012, A59197-025, A59197-026, A59197-027, A59197-028, A59197-029, A59197-030, A59197-031, A59197-032, A59197-033, A56911-019, A56911-021, A56911-022, A56911-060, A56911-061, A56911-062, A56911-063, A56911-064, A56911-065, A56911-066, A57248-030, A57248-031, A57248-035, A59197-038, A59197-039, A59197-060, A59197-061, A57248-038, A59197-054, A47028-045, A47028-046, A47028-047, A47028-048, A59197-014, A59197-015, A59197-016, A59197-017, A56911-069, A59197-045, A57248-015, A57248-016, A57248-017, A57248-018, A56911-036, A56911-037, A56911-038, A56911-039, A56911-040, A47028-049, A47028-050, A47028-051, A47028-052, A57248-037, A59197-064, A59197-065, A47028-054, A59197-042, A59197-043, A59197-053, A56911-026, A59197-056, A57248-019, A47028-055, A47028-056, A59197-046, A59197-063, A59197-058, A47028-057, A47028-058, A59197-035; d) T44150: GTIN 00643169122932, Serial Numbers: A48245-164, A48245-168, A57914-011, A57914-012, A57914-023, A57914-024, A57914-025, A59191-061, A59191-058, A58758-035, A58758-036, A58758-037, A58758-059, A59191-038, A59191-039, A58758-034, A58758-038, A59191-040, A48245-121, A48245-122, A48245-123, A48245-124, A48245-147, A48245-148, A48245-149, A48245-160, A48245-170, A58758-060, A58758-061, A58758-062, A59191-062, A59191-063, A59191-064, A58758-039, A57914-013, A57914-014, A57914-015, A57914-016, A57914-017, A58758-040, A58758-041, A58758-042, A59191-041, A58758-043, A58758-044, A48245-165, A48245-166, A48245-167, A48245-169, A58758-045, A58758-046, A58758-050, A58758-051, A58758-047, A58758-048, A58758-049, A59191-042, A59191-043, A59191-044, A58758-031, A58758-032, A58758-033, A59191-045, A59191-046, A59191-047, A59191-048, A59191-049, A48245-135, A48245-136, A48245-137, A48245-138, A48245-139, A48245-140, A48245-141, A48245-142, A48245-143, A48245-144, A48245-145, A48245-146, A48245-150, A48245-151, A48245-152, A48245-153, A48245-154, A48245-155, A48245-156, A48245-157, A57914-018, A57914-019, A57914-020, A57914-021, A57914-022, A48245-161, A48245-125, A48245-126, A48245-127, A48245-128, A48245-129, A48245-130, A48245-131, A48245-132, A48245-133, A48245-134, A48245-158, A48245-159, A48245-162, A59191-050, A59191-051, A48245-163, A58758-052, A59191-052, A59191-053, A58758-063, A59191-060, A58758-053, A58758-054, A58758-055, A59191-054, A59191-055, A59191-059, A58758-056, A58758-057, A58758-058, A59191-056, A59191-057

Distribution pattern

US, Colombia, S. Korea, New Zealand, India, Taiwan

device · product 6 of 7

Grafton Plus DBM Paste, Model Numbers: a) T45001, b) T45005, c) T45010; Demineralized Bone Matrix

Z-0166-2024
Recall number
Z-0166-2024
Initiated
September 26, 2023
Classification
Class II
Status
Ongoing
Quantity
583 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch.

Code information

a) T45001: GTIN 00643169122949, Serial Numbers: A48245-111, A58751-114, A57260-060, A57260-063, A58751-112, A58751-113, A57260-083, A57260-084, A58428-149, A58428-150, A57260-082, A58428-148, A58751-111, A57260-078, A58428-141, A48245-075, A48245-076, A57260-075, A58751-096, A57260-079, A58428-147, A58428-128, A57260-072, A57260-059, A57260-067, A57260-068, A57260-069, A48245-105, A48245-106, A57256-160, A58751-100, A57256-161, A48245-113, A57256-164, A58799-167, A58799-168, A58799-169, A58799-170, A58799-171, A57256-170, A48245-107, A48245-108, A57256-136, A58751-108, A48245-079, A48245-082, A48245-083, A48245-084, A48245-086, A58751-070, A58751-071, A58751-072, A58751-073, A58751-074, A58751-075, A58751-076, A58751-115, A58799-087, A48245-101, A58799-165, A58799-166, A48245-032, A48245-033, A48245-034, A48245-035, A48245-036, A57260-058, A58799-143, A58799-144, A48245-098, A48245-099, A58428-099, A58428-100, A58428-101, A58428-102, A58428-103, A57260-061, A48245-026, A48245-100, A48245-027, A48245-028, A48245-029, A48245-030, A48245-031, A58751-077, A58751-078, A58751-079, A58751-080, A57260-064, A57260-065, A57260-066, A58428-086, A58428-087, A58428-088, A57256-145, A57256-146, A57256-147, A57256-148, A57256-149, A57256-150, A48245-018, A58799-099, A58799-100, A58799-113, A58799-114, A48245-053, A58799-123, A48245-080, A48245-081, A58428-107, A58428-108, A58428-109, A58428-110, A57256-137, A57256-138, A57256-139, A57256-140, A58799-107, A58799-108, A58799-109, A58751-083, A58751-084, A58751-085, A48245-022, A48245-023, A58428-111, A58428-112, A58428-113, A58428-114, A58751-086, A58751-087, A58751-088, A58751-089, A57256-172, A58428-115, A58428-116, A58799-119, A58799-120, A58799-124, A58799-125, A48245-037, A48245-038, A57256-133, A57256-134, A57256-135, A57256-142, A57256-143, A57256-144, A58751-081, A58799-172, A58799-173, A58799-174, A58799-175, A58799-176, A58799-177, A58799-092, A58799-093, A58428-117, A58428-118, A48245-019, A48245-020, A48245-021, A58799-128, A58799-129, A58799-130, A58799-131, A58799-132, A48245-087, A48245-088, A57260-080, A57260-081, A58428-119, A58799-134, A58751-090, A48245-042, A48245-043, A48245-095, A48245-096, A48245-097, A58428-120, A58428-121, A58428-122, A58751-091, A58799-135, A58799-136, A58799-137, A58799-138, A58799-139, A48245-074, A48245-094, A48245-044, A48245-045, A48245-046, A58751-093, A58751-094, A58751-095, A58428-123, A58428-124, A58428-125, A58428-144, A58428-145, A58428-146, A48245-085, A48245-116, A48245-039, A48245-040, A48245-041, A58428-104, A58428-105, A58428-106, A58799-102, A58799-103, A58799-104, A58799-105, A48245-089, A48245-090, A48245-091, A48245-092, A48245-093, A48245-077, A57260-076, A57260-077, A58428-126, A58428-127, A58799-121, A58799-122, A58799-126, A58799-127, A58799-094, A58799-095, A48245-112, A58751-097, A58751-092, A58799-097, A58799-098, A58428-130, A58428-131, A58428-132, A58428-133, A58428-134, A57260-073, A57260-074, A58799-088, A58799-089, A58799-090, A58799-091, A58799-140, A58799-141, A58799-142, A58799-145, A58799-146, A58799-147, A58799-148, A58799-149, A58799-150, A58799-151, A58799-152, A58799-153, A58799-154, A58799-155, A58799-156, A58799-157, A58799-158, A58799-159, A58799-160, A58799-161, A58799-162, A57256-171, A48245-054, A48245-055, A58751-098, A58751-099, A48245-117, A48245-118, A48245-119, A48245-120, A57260-070, A57260-071, A48245-102, A58799-101, A58799-163, A58799-164, A58799-106, A58799-110, A58799-111, A58799-112, A58799-115, A58799-116, A58799-117, A58799-118, A57256-141, A58428-139, A48245-109, A48245-110, A57256-157, A57256-158, A57256-159, A48245-114, A48245-115, A48245-056, A48245-057, A48245-068, A48245-069, A48245-070, A48245-071, A48245-072, A48245-073, A48245-078, A58751-101, A58751-102, A58751-103, A58751-104, A58751-105, A48245-048, A48245-049, A48245-050, A48245-051, A48245-052, A58428-090, A58428-091, A58428-092, A58428-093, A58428-135, A58428-136, A58751-106, A58799-133, A58751-109, A58751-110, A58751-082, A58799-096, A57256-162, A57256-163, A58428-142, A48245-058, A58428-129, A57256-165, A48245-024, A48245-025, A58428-089, A58428-143, A58751-067, A58751-068, A58751-069, A57256-166, A58428-140, A48245-047, A58428-137, A58428-138, A57256-151, A57256-152, A57256-153, A57256-154, A57256-155, A57256-156, A58428-094, A58428-095, A58428-096, A58428-097, A58428-098, A48245-059, A48245-060, A48245-061, A48245-062, A48245-063, A48245-064, A48245-065, A48245-066, A48245-067, A57260-062, A58751-107, A57256-167, A57256-168, A57256-169, A48245-103, A48245-104; b) T45005: GTIN 00643169123021, Serial Numbers: A58746-016, A57923-013, A59083-037, A57923-022, A57878-072, A58720-014, A58720-015, A57261-045, A57261-046, A57261-047, A59083-048, A58973-023, A58973-024, A58973-025, A58973-026, A58973-027, A59132-021, A59132-022, A59132-023, A59132-024, A59132-025, A59132-026, A59132-027, A59132-028, A59132-029, A59132-030, A57878-063, A57878-064, A57878-065, A57878-066, A57878-067, A58973-029, A58973-033, A58746-013, A58746-015, A58746-014, A57923-021, A59083-049, A57923-011, A57923-012, A58746-018, A58746-019, A58746-020, A58746-021, A58746-024, A57878-068, A57878-069, A58973-028, A58746-023, A58746-025, A58746-029, A58746-030, A58746-031, A58746-032, A57878-070, A57878-071, A58746-026, A58746-027, A57923-014, A57923-015, A57261-039, A57261-040, A57261-041, A57261-042, A57261-043, A57261-044, A58746-028, A59083-036, A59083-038, A58746-011, A58746-012, A58746-017, A58973-011, A58973-012, A58973-013, A58973-014, A58973-015, A58973-016, A58973-017, A58973-018, A58973-019, A58973-020, A58973-021, A58973-022, A58720-023, A57878-073, A57878-074, A57261-038, A59083-039, A59083-040, A59083-041, A57261-056, A57878-075, A57878-076, A57261-048, A57261-049, A57261-050, A58720-011, A58720-012, A57261-051, A57261-052, A59083-042, A57261-055, A57261-057, A59083-043, A57261-053, A57261-054, A58720-013, A58720-016, A58720-017, A59083-044, A57923-016, A57923-017, A57923-018, A57923-023, A58973-030, A58973-031, A59083-045, A59129-032, A59129-041, A57923-019, A58720-018, A58720-019, A58720-020, A58720-021, A58720-022, A58973-032, A57923-020, A59083-046, A59083-047, A58746-022, A59132-011, A59132-012, A59132-013, A59132-014, A59132-015, A59132-016, A59132-017, A59132-018, A59132-019, A59132-020; c) T45010: GTIN 00643169123038, Serial Numbers: A59231-018, A59231-019, A56269-064, A59231-014, A56269-066, A59010-019, A59010-021, A59010-022, A59010-023, A56269-071, A56269-072, A59356-017, A59356-018, A59131-019, A59131-020, A59191-026, A59231-020, A59231-015, A59231-016, A59231-017, A59010-024, A59010-025, A56269-065, A59131-011, A59131-012, A59131-013, A59356-011, A59356-012, A59356-013, A59231-013, A56269-061, A56269-062, A56269-063, A59010-026, A59010-027, A59131-014, A59131-015, A59131-016, A59131-017, A59131-018, A59191-027, A59191-028, A59191-029, A59191-030, A59191-031, A59191-032, A59191-033, A59010-020, A56269-067, A56269-068, A59191-034, A59191-035, A59191-036, A59356-020, A59191-037, A59231-011, A59356-019, A56269-069, A56269-070, A59010-016, A59010-017, A59231-012, A59356-014, A59356-015, A56269-060, A59010-018, A59356-016

Distribution pattern

US, Colombia, S. Korea, New Zealand, India, Taiwan

device · product 7 of 7

Grafton DBM Putty, Model Numbers: a) T43102, b) T43102INT, c) T43103INT, d) T43105, e) T43105INT, f) T43110, g) T43110INT; Demineralized Bone Matrix

Z-0167-2024
Recall number
Z-0167-2024
Initiated
September 26, 2023
Classification
Class II
Status
Ongoing
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch.

Code information

a) T43102: b) T43102INT: c) T43103INT: d) T43105: e) T43105INT: f) T43110: g) T43110INT:

Distribution pattern

US, Colombia, S. Korea, New Zealand, India, Taiwan