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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86462

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

Open FDA event record

Event summary

Timeline bucket
September 09, 2020
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Smith & Nephew, 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

40 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 40

TWINFIX 5.0MM AB SUTURE ANCHOR WITH TWO Absorbable Suture anchors Product Number: 7210309

Z-0136-2021
Recall number
Z-0136-2021
Initiated
September 09, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Smith & Nephew, Inc.
Quantity
263,874 (total)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
incomplete seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

Code information

Batch Number: 2030895

Distribution pattern

Nationwide Foreign: AE, AT, AU, BE, BM, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DO, EC, EE, ES, FI, FR, GB, GE, GR, HK, HU, IE, IL, IN, IT, JP,KR, LV,MY, NL, NO, PA,PE, PL, PR, PT, RU, SE, SG, SI, TH, TR, TW, UA, & ZA

device · product 2 of 40

TWINFIX 5.0MM AB SUTURE ANCHOR WITH TWO- Absorbable Suture anchors Product Number: 7210710

Z-0137-2021
Recall number
Z-0137-2021
Initiated
September 09, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Smith & Nephew, Inc.
Quantity
263,874 (total)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
incomplete seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

Code information

Batch Numbers: 2025362, 2040057

Distribution pattern

Nationwide Foreign: AE, AT, AU, BE, BM, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DO, EC, EE, ES, FI, FR, GB, GE, GR, HK, HU, IE, IL, IN, IT, JP,KR, LV,MY, NL, NO, PA,PE, PL, PR, PT, RU, SE, SG, SI, TH, TR, TW, UA, & ZA

device · product 3 of 40

TWINFIX 5.0MM AB SUTURE ANCHOR-Absorbable Suture anchors Product Number: 7210711

Z-0138-2021
Recall number
Z-0138-2021
Initiated
September 09, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Smith & Nephew, Inc.
Quantity
263,874 (total)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
incomplete seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

Code information

Batch Numbers: 2025421, 2038665,

Distribution pattern

Nationwide Foreign: AE, AT, AU, BE, BM, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DO, EC, EE, ES, FI, FR, GB, GE, GR, HK, HU, IE, IL, IN, IT, JP,KR, LV,MY, NL, NO, PA,PE, PL, PR, PT, RU, SE, SG, SI, TH, TR, TW, UA, & ZA

device · product 4 of 40

TWINFIX 6.5MM AB PRELOADED ULTRABRAID- Absorbable Suture anchors Product Number: 7210712

Z-0139-2021
Recall number
Z-0139-2021
Initiated
September 09, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Smith & Nephew, Inc.
Quantity
263,874 (total)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
incomplete seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

Code information

Batch Numbers: 2025178

Distribution pattern

Nationwide Foreign: AE, AT, AU, BE, BM, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DO, EC, EE, ES, FI, FR, GB, GE, GR, HK, HU, IE, IL, IN, IT, JP,KR, LV,MY, NL, NO, PA,PE, PL, PR, PT, RU, SE, SG, SI, TH, TR, TW, UA, & ZA

device · product 5 of 40

TWINFIX 6.5MM AB PRELOADED SUTURE ANCHOR- Absorbable Suture anchors Product Number: 7210713

Z-0140-2021
Recall number
Z-0140-2021
Initiated
September 09, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Smith & Nephew, Inc.
Quantity
263,874 (total)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
incomplete seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

Code information

Batch Numbers: 2027380

Distribution pattern

Nationwide Foreign: AE, AT, AU, BE, BM, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DO, EC, EE, ES, FI, FR, GB, GE, GR, HK, HU, IE, IL, IN, IT, JP,KR, LV,MY, NL, NO, PA,PE, PL, PR, PT, RU, SE, SG, SI, TH, TR, TW, UA, & ZA

device · product 6 of 40

TWINFIX AB 5.0 SUTR ANCHR W/2 38 ULTRA-Absorbable Suture anchors Product Number:72200777

Z-0141-2021
Recall number
Z-0141-2021
Initiated
September 09, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Smith & Nephew, Inc.
Quantity
263,874 (total)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
incomplete seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

Code information

Batch Numbers: 2012914, 2033371

Distribution pattern

Nationwide Foreign: AE, AT, AU, BE, BM, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DO, EC, EE, ES, FI, FR, GB, GE, GR, HK, HU, IE, IL, IN, IT, JP,KR, LV,MY, NL, NO, PA,PE, PL, PR, PT, RU, SE, SG, SI, TH, TR, TW, UA, & ZA

device · product 7 of 40

TWINFIX AB 5.0 SUTR ANCHR W/2 38 DURAB-Absorbable Suture anchors Product Number: 72200785

Z-0142-2021
Recall number
Z-0142-2021
Initiated
September 09, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Smith & Nephew, Inc.
Quantity
263,874 (total)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
incomplete seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

Code information

Batch Numbers: 2044764

Distribution pattern

Nationwide Foreign: AE, AT, AU, BE, BM, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DO, EC, EE, ES, FI, FR, GB, GE, GR, HK, HU, IE, IL, IN, IT, JP,KR, LV,MY, NL, NO, PA,PE, PL, PR, PT, RU, SE, SG, SI, TH, TR, TW, UA, & ZA

device · product 8 of 40

ULTRA FAST-FIX AB ASSEMBLY - STRAIGHT-Absorbable Suture anchors Product Number: 72201493

Z-0143-2021
Recall number
Z-0143-2021
Initiated
September 09, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Smith & Nephew, Inc.
Quantity
N/A

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
incomplete seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

Code information

Batch Numbers: 2024948, 2024949, 2027356,2029176, 2044635

Distribution pattern

Nationwide Foreign: AE, AT, AU, BE, BM, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DO, EC, EE, ES, FI, FR, GB, GE, GR, HK, HU, IE, IL, IN, IT, JP,KR, LV,MY, NL, NO, PA,PE, PL, PR, PT, RU, SE, SG, SI, TH, TR, TW, UA, & ZA

device · product 9 of 40

ULTRA FAST-FIX AB ASSEMBLY - CURVED-Absorbable Suture anchors Product Number: 72201494

Z-0144-2021
Recall number
Z-0144-2021
Initiated
September 09, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Smith & Nephew, Inc.
Quantity
263,874 (total)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
incomplete seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

Code information

Batch Numbers: 2023195 2023243 2024953 2024956 2025090 2025122 2025379 2025380 2026563 2028643 2027357 2027362 2027367 2027371 2029177 2029178 2029179 2029180 2029213 2030836 2030837 2030853 2030854 2030869 2030870 2030871 2030872 2030883 2030884 2032840 2033307 2033418 2033554 2035383 2035384 2035403 2035404 2035413 2035428 2036762 2036763 2037209 2038262 2040397 2040398 2039496 2039175 2039633 2039634 2041088 2041089 2041214 2044784 2042798 2044783 2045734 2045735 2046221 2048174 2048173 2048175 2048176 2048177 2049628 2049629 2049630 2049631 2049632 2050866 2050867 2051658 2050868 2050869 2052035 2053332 2053334 2050865 2053333 2053335 2053336 2053337 2054832 2055528 2054776 2054777 2054778

Distribution pattern

Nationwide Foreign: AE, AT, AU, BE, BM, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DO, EC, EE, ES, FI, FR, GB, GE, GR, HK, HU, IE, IL, IN, IT, JP,KR, LV,MY, NL, NO, PA,PE, PL, PR, PT, RU, SE, SG, SI, TH, TR, TW, UA, & ZA

device · product 10 of 40

ULTRA FAST-FIX AB ASSEMBLY-REVERSE CURVE-Absorbable Suture anchor Product Number: 72201495

Z-0145-2021
Recall number
Z-0145-2021
Initiated
September 09, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Smith & Nephew, Inc.
Quantity
263,874 (total)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
incomplete seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

Code information

Batch Numbers: 2020371 2020372 2020373 2020995 2030838 2035405 2044636 2048178

Distribution pattern

Nationwide Foreign: AE, AT, AU, BE, BM, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DO, EC, EE, ES, FI, FR, GB, GE, GR, HK, HU, IE, IL, IN, IT, JP,KR, LV,MY, NL, NO, PA,PE, PL, PR, PT, RU, SE, SG, SI, TH, TR, TW, UA, & ZA

device · product 11 of 40

BIORAPTOR 2.9MM SUTURE ANCHOR-Absorbable Suture anchor Product Number: 72201702

Z-0146-2021
Recall number
Z-0146-2021
Initiated
September 09, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Smith & Nephew, Inc.
Quantity
263,874 (total)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
incomplete seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

Code information

Batch Numbers: 2029229 2034457 2040701 2050876

Distribution pattern

Nationwide Foreign: AE, AT, AU, BE, BM, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DO, EC, EE, ES, FI, FR, GB, GE, GR, HK, HU, IE, IL, IN, IT, JP,KR, LV,MY, NL, NO, PA,PE, PL, PR, PT, RU, SE, SG, SI, TH, TR, TW, UA, & ZA

device · product 12 of 40

RAPTORMITE 3.7MM AB W/ NEEDLES AND TWO-Absorbable Suture anchor Product Number: 72201805

Z-0147-2021
Recall number
Z-0147-2021
Initiated
September 09, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Smith & Nephew, Inc.
Quantity
263,874 (total)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
incomplete seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

Code information

Batch Numbers: 2025354 2031116 2040066 2040702 2042557 2049638 2053749 2055239

Distribution pattern

Nationwide Foreign: AE, AT, AU, BE, BM, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DO, EC, EE, ES, FI, FR, GB, GE, GR, HK, HU, IE, IL, IN, IT, JP,KR, LV,MY, NL, NO, PA,PE, PL, PR, PT, RU, SE, SG, SI, TH, TR, TW, UA, & ZA

device · product 13 of 40

OSTEORAPTOR 2.3 W 1UB II BLUE-Absorbable Suture anchor Product Number: 72201991

Z-0148-2021
Recall number
Z-0148-2021
Initiated
September 09, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Smith & Nephew, Inc.
Quantity
263,874 (total)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
incomplete seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

Code information

Batch Numbers: 2012767 2013997 2016120 2017772 2018792 2019839 2021494 2022257 2024709 2025285 2027451 2027481 2030907 2030908 2031041 2033235 2033236 2034376 2034377 2034378 2035450 2036270 2049647 2049648 2053756 2049649 2050880 2050881 2056052 2056053

Distribution pattern

Nationwide Foreign: AE, AT, AU, BE, BM, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DO, EC, EE, ES, FI, FR, GB, GE, GR, HK, HU, IE, IL, IN, IT, JP,KR, LV,MY, NL, NO, PA,PE, PL, PR, PT, RU, SE, SG, SI, TH, TR, TW, UA, & ZA

device · product 14 of 40

OSTEORAPTOR 2.3 W/ 1 UB COBRAID BLACK-Absorbable Suture anchor Product Number: 72201992

Z-0149-2021
Recall number
Z-0149-2021
Initiated
September 09, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Smith & Nephew, Inc.
Quantity
263,874 (total)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
incomplete seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

Code information

Batch Numbers: 2012908 2016123 2017811 2018793 2018796 2019889 2023270 2024438 2025338 2027482 2029362 2032556 2033493 2034379 2034380 2034381 2036272 2036273 2038763 2050882 2050883 2049650 2049651 2053757 2056870

Distribution pattern

Nationwide Foreign: AE, AT, AU, BE, BM, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DO, EC, EE, ES, FI, FR, GB, GE, GR, HK, HU, IE, IL, IN, IT, JP,KR, LV,MY, NL, NO, PA,PE, PL, PR, PT, RU, SE, SG, SI, TH, TR, TW, UA, & ZA

device · product 15 of 40

OSTEORAPTOR 2.3 W. UB COBRAID BLUE-Absorbable Suture anchor Product Number: 72201993

Z-0150-2021
Recall number
Z-0150-2021
Initiated
September 09, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Smith & Nephew, Inc.
Quantity
263,874 (total)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
incomplete seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

Code information

Batch Numbers: 2012768 2013311 2012721 2013998 2016127 2018633 2018634 2019989 2020049 2021384 2021453 2023181 2023223 2023335 2025106 2025286 2026922 2025140 2026921 2026923 2025339 2027417 2027452 2029072 2029363 2030909 2030910 2030911 2030985 2030983 2030984 2032785 2033372 2033373 2034382 2034383 2034384 2035515 2035516 2035517 2035518 2036275 2036276 2039986 2038899 2039421 2039422 2040069 2040070 2040071 2044789 2044790 2044791 2050884 2049652 2049653 2050885 2055771 2055772 2056306 2048187 2056871 2056307

Distribution pattern

Nationwide Foreign: AE, AT, AU, BE, BM, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DO, EC, EE, ES, FI, FR, GB, GE, GR, HK, HU, IE, IL, IN, IT, JP,KR, LV,MY, NL, NO, PA,PE, PL, PR, PT, RU, SE, SG, SI, TH, TR, TW, UA, & ZA

device · product 16 of 40

OSTEORAPTOR 2.9 W/ 1 UB COBRAID BLUE -Absorbable Suture anchor Product Number: 72201994

Z-0151-2021
Recall number
Z-0151-2021
Initiated
September 09, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Smith & Nephew, Inc.
Quantity
263,874 (total)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
incomplete seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

Code information

Batch Numbers: 2012769 2013999 2016154 2021495 2023224 2025101 2026924 2027418 2029364 2030912 2030913 2033496 2036691 2049654 2053758 2050886

Distribution pattern

Nationwide Foreign: AE, AT, AU, BE, BM, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DO, EC, EE, ES, FI, FR, GB, GE, GR, HK, HU, IE, IL, IN, IT, JP,KR, LV,MY, NL, NO, PA,PE, PL, PR, PT, RU, SE, SG, SI, TH, TR, TW, UA, & ZA

device · product 17 of 40

OSTEORAPTOR 2.9 W/ 2 UB WHITE / BLUE -Absorbable Suture anchor Product Number: 72201995

Z-0152-2021
Recall number
Z-0152-2021
Initiated
September 09, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Smith & Nephew, Inc.
Quantity
N/A

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
incomplete seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

Code information

Batch Numbers: 2012909 2012911 2012910 2012937 2013912 2013913 2016202 2016230 2016203 2018636 2018637 2018740 2018795 2021326 2022258 2023091 2024440 2024441 2024439 2024448 2024449 2025098 2025094 2025340 2025287 2027419 2027388 2025288 2027453 2029073 2027483 2029325 2029326 2029366 2029365 2030990 2030989 2031123 2031125 2031127 2032788 2033240 2033239 2033375 2033376 2033497 2034385 2034386 2034387 2034458 2034459 2035471 2035472 2035473 2035521 2035522 2035523 2035524 2035526 2035525 2036692 2039227 2039228 2039424 2039584 2039585 2040072 2040706 2040708 2040709 2042563 2042564 2042565 2042745 2042746 2044792 2044794 2044795 2044796 2044797 2044793 2045742 2045743 2045744 2045745 2045746 2046744 2048188 2048189 2048190 2048191 2048192 2049661 2049662 2049655 2049656 2049657 2049658 2049660 2049659 2056309 2056311 2056310 2056312 2056313

Distribution pattern

Nationwide Foreign: AE, AT, AU, BE, BM, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DO, EC, EE, ES, FI, FR, GB, GE, GR, HK, HU, IE, IL, IN, IT, JP,KR, LV,MY, NL, NO, PA,PE, PL, PR, PT, RU, SE, SG, SI, TH, TR, TW, UA, & ZA

device · product 18 of 40

OSTEORAPTOR 2.9 W. 2 UB WHITE / BLACK -Absorbable Suture anchor Product Number: 72201996

Z-0153-2021
Recall number
Z-0153-2021
Initiated
September 09, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Smith & Nephew, Inc.
Quantity
N/A

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
incomplete seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

Code information

Batch Numbers: 2012912 2017844 2019840 2021496 2024714 2033500 2049663 2052725 2055727

Distribution pattern

Nationwide Foreign: AE, AT, AU, BE, BM, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DO, EC, EE, ES, FI, FR, GB, GE, GR, HK, HU, IE, IL, IN, IT, JP,KR, LV,MY, NL, NO, PA,PE, PL, PR, PT, RU, SE, SG, SI, TH, TR, TW, UA, & ZA

device · product 19 of 40

OSTEORAPTOR 2.9 W 1UB II BLUE--Absorbable Suture anchor Product Number: 72202165

Z-0154-2021
Recall number
Z-0154-2021
Initiated
September 09, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Smith & Nephew, Inc.
Quantity
263,874 (total)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
incomplete seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

Code information

Batch Numbers: 2012722 2025144

Distribution pattern

Nationwide Foreign: AE, AT, AU, BE, BM, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DO, EC, EE, ES, FI, FR, GB, GE, GR, HK, HU, IE, IL, IN, IT, JP,KR, LV,MY, NL, NO, PA,PE, PL, PR, PT, RU, SE, SG, SI, TH, TR, TW, UA, & ZA

device · product 20 of 40

TWINFIX ULTRA 5.5MM PLLA/HA 2 UBWHT/BL--Absorbable Suture anchor Product Number: 72202602

Z-0155-2021
Recall number
Z-0155-2021
Initiated
September 09, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Smith & Nephew, Inc.
Quantity
263,874 (total)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
incomplete seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

Code information

Batch Numbers: 2013151 2013152 2013903 2016145 2017808 2018788 2019884 2019885 2025277 2027457 2031003 2031002 2031054 2031055 2033509 2033508 2034401 2038771 2042570 2042752 2048296 2049809 2050955 2053788 2056330 2056872

Distribution pattern

Nationwide Foreign: AE, AT, AU, BE, BM, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DO, EC, EE, ES, FI, FR, GB, GE, GR, HK, HU, IE, IL, IN, IT, JP,KR, LV,MY, NL, NO, PA,PE, PL, PR, PT, RU, SE, SG, SI, TH, TR, TW, UA, & ZA

device · product 21 of 40

TWINFIX ULTRA PLLA/HA 5.5 W/3 UB-Absorbable Suture anchor Product Number: 72202603

Z-0156-2021
Recall number
Z-0156-2021
Initiated
September 09, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Smith & Nephew, Inc.
Quantity
263,874 (total)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
incomplete seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

Code information

Batch Numbers: 2012913 2024716 2025341 2031135 2033510 2034402 2036289 2037671

Distribution pattern

Nationwide Foreign: AE, AT, AU, BE, BM, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DO, EC, EE, ES, FI, FR, GB, GE, GR, HK, HU, IE, IL, IN, IT, JP,KR, LV,MY, NL, NO, PA,PE, PL, PR, PT, RU, SE, SG, SI, TH, TR, TW, UA, & ZA

device · product 22 of 40

TWINFIX ULTRA 6.5MM PLLA/HA 2 UBWHT/BL-Absorbable Suture anchor Product Number: 72202608

Z-0157-2021
Recall number
Z-0157-2021
Initiated
September 09, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Smith & Nephew, Inc.
Quantity
263,874 (total)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
incomplete seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

Code information

Batch Numbers: 2012718

Distribution pattern

Nationwide Foreign: AE, AT, AU, BE, BM, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DO, EC, EE, ES, FI, FR, GB, GE, GR, HK, HU, IE, IL, IN, IT, JP,KR, LV,MY, NL, NO, PA,PE, PL, PR, PT, RU, SE, SG, SI, TH, TR, TW, UA, & ZA

device · product 23 of 40

TWINFIX ULTRA PLLA/HA 6.5 W/3 UB- Absorbable Suture anchor Product Number: 72202610

Z-0158-2021
Recall number
Z-0158-2021
Initiated
September 09, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Smith & Nephew, Inc.
Quantity
263,874 (total)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
incomplete seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

Code information

Batch Numbers: 2024447 2039587

Distribution pattern

Nationwide Foreign: AE, AT, AU, BE, BM, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DO, EC, EE, ES, FI, FR, GB, GE, GR, HK, HU, IE, IL, IN, IT, JP,KR, LV,MY, NL, NO, PA,PE, PL, PR, PT, RU, SE, SG, SI, TH, TR, TW, UA, & ZA

device · product 24 of 40

TWINFIX ULTRA PLLA HA 4.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202612

Z-0159-2021
Recall number
Z-0159-2021
Initiated
September 09, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Smith & Nephew, Inc.
Quantity
263,874 (total)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
incomplete seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

Code information

Batch Numbers: 2027487 2031136 2033257 2034471 2038440 2050957 2053792 2056056

Distribution pattern

Nationwide Foreign: AE, AT, AU, BE, BM, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DO, EC, EE, ES, FI, FR, GB, GE, GR, HK, HU, IE, IL, IN, IT, JP,KR, LV,MY, NL, NO, PA,PE, PL, PR, PT, RU, SE, SG, SI, TH, TR, TW, UA, & ZA

device · product 25 of 40

TWINFIX ULTRA PLLA HA 5.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202616

Z-0160-2021
Recall number
Z-0160-2021
Initiated
September 09, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Smith & Nephew, Inc.
Quantity
263,874 (total)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
incomplete seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

Code information

Batch Numbers: 2025074 2027489 2031006 2042572 2052109 2056058

Distribution pattern

Nationwide Foreign: AE, AT, AU, BE, BM, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DO, EC, EE, ES, FI, FR, GB, GE, GR, HK, HU, IE, IL, IN, IT, JP,KR, LV,MY, NL, NO, PA,PE, PL, PR, PT, RU, SE, SG, SI, TH, TR, TW, UA, & ZA

device · product 26 of 40

TWINFIX ULTRA PLLA HA 6.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202620

Z-0161-2021
Recall number
Z-0161-2021
Initiated
September 09, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Smith & Nephew, Inc.
Quantity
263,874 (total)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
incomplete seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

Code information

Batch Numbers: 2025072

Distribution pattern

Nationwide Foreign: AE, AT, AU, BE, BM, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DO, EC, EE, ES, FI, FR, GB, GE, GR, HK, HU, IE, IL, IN, IT, JP,KR, LV,MY, NL, NO, PA,PE, PL, PR, PT, RU, SE, SG, SI, TH, TR, TW, UA, & ZA

device · product 27 of 40

TWINFIX ULTRA HA 4.5 W/2 UB BLUE & BLK- Absorbable Suture anchor Product Number: 72202624

Z-0162-2021
Recall number
Z-0162-2021
Initiated
September 09, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Smith & Nephew, Inc.
Quantity
263,874 (total)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
incomplete seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

Code information

Batch Numbers: 2013904 2018628 2023177 2025213 2039590 2050959 2052719

Distribution pattern

Nationwide Foreign: AE, AT, AU, BE, BM, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DO, EC, EE, ES, FI, FR, GB, GE, GR, HK, HU, IE, IL, IN, IT, JP,KR, LV,MY, NL, NO, PA,PE, PL, PR, PT, RU, SE, SG, SI, TH, TR, TW, UA, & ZA

device · product 28 of 40

TWINFIX ULTRA HA 5.5 W/2 UB BLUE & BLK- Absorbable Suture anchor Product Number: 72202626

Z-0163-2021
Recall number
Z-0163-2021
Initiated
September 09, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Smith & Nephew, Inc.
Quantity
N/A

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
incomplete seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

Code information

Batch Numbers: 2012719 2024702 2027393 2029380

Distribution pattern

Nationwide Foreign: AE, AT, AU, BE, BM, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DO, EC, EE, ES, FI, FR, GB, GE, GR, HK, HU, IE, IL, IN, IT, JP,KR, LV,MY, NL, NO, PA,PE, PL, PR, PT, RU, SE, SG, SI, TH, TR, TW, UA, & ZA

device · product 29 of 40

TWINFIX ULTRA HA 6.5 W/2 UB (BLUE & BLK)- Absorbable Suture anchor Product Number: 72202631

Z-0164-2021
Recall number
Z-0164-2021
Initiated
September 09, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Smith & Nephew, Inc.
Quantity
263,874 (total)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
incomplete seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

Code information

Batch Numbers: 2012720 2024445 2052779 2055899

Distribution pattern

Nationwide Foreign: AE, AT, AU, BE, BM, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DO, EC, EE, ES, FI, FR, GB, GE, GR, HK, HU, IE, IL, IN, IT, JP,KR, LV,MY, NL, NO, PA,PE, PL, PR, PT, RU, SE, SG, SI, TH, TR, TW, UA, & ZA

device · product 30 of 40

OSTEORAPTOR CRVD 2.3 SA UB COBRD BLUE- Absorbable Suture anchor Product Number: 72203290

Z-0165-2021
Recall number
Z-0165-2021
Initiated
September 09, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Smith & Nephew, Inc.
Quantity
263,874 (total)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
incomplete seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

Code information

Batch Numbers: 2012935 2013910 2016229 2017812 2018635 2019990 2021454 2022268 2024711 2025147 2027400 2029394 2030945 2037184 2038460 2038795 2039253 2039444 2045859 2045858 2045860 2045861 2048368 2049884 2048367

Distribution pattern

Nationwide Foreign: AE, AT, AU, BE, BM, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DO, EC, EE, ES, FI, FR, GB, GE, GR, HK, HU, IE, IL, IN, IT, JP,KR, LV,MY, NL, NO, PA,PE, PL, PR, PT, RU, SE, SG, SI, TH, TR, TW, UA, & ZA

device · product 31 of 40

OSTEORAPTOR CRVD 2.3 SA UB COBRD BLACK- Absorbable Suture anchor Product Number: 72203291

Z-0166-2021
Recall number
Z-0166-2021
Initiated
September 09, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Smith & Nephew, Inc.
Quantity
263,874 (total)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
incomplete seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

Code information

Batch Numbers: 2012936 2013911 2016129 2018794 2027463 2029395 2033280

Distribution pattern

Nationwide Foreign: AE, AT, AU, BE, BM, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DO, EC, EE, ES, FI, FR, GB, GE, GR, HK, HU, IE, IL, IN, IT, JP,KR, LV,MY, NL, NO, PA,PE, PL, PR, PT, RU, SE, SG, SI, TH, TR, TW, UA, & ZA

device · product 32 of 40

HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL- Absorbable Suture anchor Product Number: 72203697

Z-0167-2021
Recall number
Z-0167-2021
Initiated
September 09, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Smith & Nephew, Inc.
Quantity
263,874 (total)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
incomplete seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

Code information

Batch Numbers: 2013959 2016246 2017861 2018756 2019936 2021510 2023286 2024791 2025371 2027465 2027498 2027403 2029347 2031019 2031087 2031153 2033535 2035497 2035534 2037188 2037148 2038325 2039607 2041068 2042774 2044894 2046452 2048384 2048385 2049906 2051015 2051016 2052167 2052166 2056074 2056423 2056424 2057383

Distribution pattern

Nationwide Foreign: AE, AT, AU, BE, BM, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DO, EC, EE, ES, FI, FR, GB, GE, GR, HK, HU, IE, IL, IN, IT, JP,KR, LV,MY, NL, NO, PA,PE, PL, PR, PT, RU, SE, SG, SI, TH, TR, TW, UA, & ZA

device · product 33 of 40

HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL-- Absorbable Suture anchor Product Number: 72203704

Z-0168-2021
Recall number
Z-0168-2021
Initiated
September 09, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Smith & Nephew, Inc.
Quantity
263,874 (total)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
incomplete seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

Code information

Batch Numbers: 2014657 2013922 2013943 2013986 2016204 2016148 2016205 2016243 2017825 2017855 2017857 2018810 2018751 2018750 2021052 2020060 2020061 2020062 2021397 2021459 2021463 2023236 2023281 2023282 2023341 2024779 2024736 2024781 2024825 2024827 2025052 2025053 2024829 2025199 2025201 2025430 2027466 2027433 2027499 2029348 2029349 2029397 2029396 2027404 2030950 2030951 2031020 2031021 2031154 2031155 2032822 2032823 2033289 2033288 2034424 2034425 2034497 2035498 2035499 2035535 2035536 2034496 2036303 2036304 2034494 2034495 2036723 2037189 2037149 2037150 2038326 2038327 2038468 2038467 2038802 2039670 2039262 2039450 2039608 2040107 2041200 2041069 2042595 2042596 2042775 2042776 2045868 2048386 2048387 2048388 2048389 2049911 2049912 2049907 2049909 2049910 2049908 2052168 2053908 2053909 2053910 2053911 2056075 2056076 2056077 2056078 2056079 2056425

Distribution pattern

Nationwide Foreign: AE, AT, AU, BE, BM, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DO, EC, EE, ES, FI, FR, GB, GE, GR, HK, HU, IE, IL, IN, IT, JP,KR, LV,MY, NL, NO, PA,PE, PL, PR, PT, RU, SE, SG, SI, TH, TR, TW, UA, & ZA

device · product 34 of 40

HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BK-- Absorbable Suture anchor Product Number: 72203705

Z-0169-2021
Recall number
Z-0169-2021
Initiated
September 09, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Smith & Nephew, Inc.
Quantity
263,874 (total)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
incomplete seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

Code information

Batch Numbers: 2013957 2013995 2013996 2016209 2016207 2017775 2017860 2018647 2019852 2019853 2021462 2023240 2023345 2024841 2024742 2026562 2025370 2025438 2027467 2025207 2027434 2027500 2027405 2029350 2029351 2030952 2031022 2031088 2031089 2031156 2033536 2034426 2035500 2034498 2037191 2037151 2039451 2039609 2041070 2042597 2042777 2048390 2048391 2049913 2051216 2049914 2051654 2051655 2051656 2051657 2053912 2053913 2056080 2056081 2056426

Distribution pattern

Nationwide Foreign: AE, AT, AU, BE, BM, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DO, EC, EE, ES, FI, FR, GB, GE, GR, HK, HU, IE, IL, IN, IT, JP,KR, LV,MY, NL, NO, PA,PE, PL, PR, PT, RU, SE, SG, SI, TH, TR, TW, UA, & ZA

device · product 35 of 40

HEALICOIL RG SA 5.5MM W/2 UB-BL CBR BL-- Absorbable Suture anchor Product Number: 72203706

Z-0170-2021
Recall number
Z-0170-2021
Initiated
September 09, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Smith & Nephew, Inc.
Quantity
263,874 (total)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
incomplete seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

Code information

Batch Numbers: 2013923 2013951 2013987 2016163 2017827 2017828 2018645 2018644 2018753 2020065 2021559 2024738 2024839 2025433 2025435 2025436 2025367 2027468 2027435 2027501 2029263 2029398 2031090 2031091 2034427 2034428 2035537 2035538 2035539 2036725 2041201 2041202 2045870 2045869 2048392 2048394 2048395 2049915 2049916 2052172 2052173 2052174 2052175 2052177 2048393 2056427 2056428

Distribution pattern

Nationwide Foreign: AE, AT, AU, BE, BM, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DO, EC, EE, ES, FI, FR, GB, GE, GR, HK, HU, IE, IL, IN, IT, JP,KR, LV,MY, NL, NO, PA,PE, PL, PR, PT, RU, SE, SG, SI, TH, TR, TW, UA, & ZA

device · product 36 of 40

HEALICOIL RG SA 5.5MM W/3 UB-BL CB BL BK- Absorbable Suture anchor Product Number: 72203707

Z-0171-2021
Recall number
Z-0171-2021
Initiated
September 09, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Smith & Nephew, Inc.
Quantity
263,874 (total)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
incomplete seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

Code information

Batch Numbers: 2011426 2011425 2011427 2014000 2014001 2016191 2016231 2016190 2017773 2017813 2017845 2018741 2018798 2018852 2019891 2019890 2020050 2021455 2021497 2021545 2023183 2023182 2023271 2024718 2024720 2024722 2027219 2027436 2027406 2029150 2029352 2029399 2030953 2030954 2031092 2031093 2031157 2031158 2032824 2032825 2033399 2033398 2033538 2033537 2035454 2035455 2035540 2035541 2036290 2036696 2037152 2038469 2038804 2038805 2039452 2039453 2039454 2039455 2041421 2041071 2041072 2041073 2041074 2042598 2042779 2042778 2045871 2045872 2045873 2045874 2045875 2044895 2046745 2048396 2048397 2048398 2048401 2048402 2048403 2049922 2049923 2049917 2049918 2048399 2049919 2049920 2049921 2051017 2051018 2051019 2052178 2052181 2052179 2052180 2052182 2052183 2053917 2053918 2053919 2053920 2056083 2053915 2056082 2048400 2056429 2056430 2056431 2057399 2057400 2057401

Distribution pattern

Nationwide Foreign: AE, AT, AU, BE, BM, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DO, EC, EE, ES, FI, FR, GB, GE, GR, HK, HU, IE, IL, IN, IT, JP,KR, LV,MY, NL, NO, PA,PE, PL, PR, PT, RU, SE, SG, SI, TH, TR, TW, UA, & ZA

device · product 37 of 40

HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BLK- Absorbable Suture anchor Product Number: 72203708

Z-0172-2021
Recall number
Z-0172-2021
Initiated
September 09, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Smith & Nephew, Inc.
Quantity
263,874 (total)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
incomplete seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

Code information

Batch Numbers: 2014002 2016196 2017814 2020051 2021388 2023272 2024724 2026266 2024759 2025289 2027469 2030955 2031023 2033400 2035501 2036291 2038328 2039263 2048404 2049924 2051020 2053921 2056432 2057402

Distribution pattern

Nationwide Foreign: AE, AT, AU, BE, BM, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DO, EC, EE, ES, FI, FR, GB, GE, GR, HK, HU, IE, IL, IN, IT, JP,KR, LV,MY, NL, NO, PA,PE, PL, PR, PT, RU, SE, SG, SI, TH, TR, TW, UA, & ZA

device · product 38 of 40

HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BL- Absorbable Suture anchor Product Number: 72203801

Z-0173-2021
Recall number
Z-0173-2021
Initiated
September 09, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Smith & Nephew, Inc.
Quantity
263,874 (total)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
incomplete seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

Code information

Batch Numbers: 2013918 2016156 2017774 2018804 2021456 2023227 2024815 2025049 2027438 2029400 2029401 2033291 2033290 2034431 2034432 2034499 2034500 2034501 2034502 2035698 2037194 2039456 2045894 2048429 2048430 2051045 2051046 2049950 2049951 2053927 2056086 2056434

Distribution pattern

Nationwide Foreign: AE, AT, AU, BE, BM, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DO, EC, EE, ES, FI, FR, GB, GE, GR, HK, HU, IE, IL, IN, IT, JP,KR, LV,MY, NL, NO, PA,PE, PL, PR, PT, RU, SE, SG, SI, TH, TR, TW, UA, & ZA

device · product 39 of 40

MICRORAPTOR REGENESORB SUTURE ANCHOR- Absorbable Suture anchor Product Number: 72204983

Z-0174-2021
Recall number
Z-0174-2021
Initiated
September 09, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Smith & Nephew, Inc.
Quantity
263,874 (total)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
incomplete seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

Code information

Batch Numbers: 2034103 2034102 2034104 2042786

Distribution pattern

Nationwide Foreign: AE, AT, AU, BE, BM, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DO, EC, EE, ES, FI, FR, GB, GE, GR, HK, HU, IE, IL, IN, IT, JP,KR, LV,MY, NL, NO, PA,PE, PL, PR, PT, RU, SE, SG, SI, TH, TR, TW, UA, & ZA

device · product 40 of 40

MICRORAPTOR REGENESORB SUTURE ANCHOR- Absorbable Suture anchor Product Number: 72204984

Z-0175-2021
Recall number
Z-0175-2021
Initiated
September 09, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Smith & Nephew, Inc.
Quantity
263,874 (total)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
incomplete seal
Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

Code information

Batch Numbers: 2042787

Distribution pattern

Nationwide Foreign: AE, AT, AU, BE, BM, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DO, EC, EE, ES, FI, FR, GB, GE, GR, HK, HU, IE, IL, IN, IT, JP,KR, LV,MY, NL, NO, PA,PE, PL, PR, PT, RU, SE, SG, SI, TH, TR, TW, UA, & ZA