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Smith & Nephew, Inc.

Smith & Nephew, Inc. Recalls

All product recalls associated with Smith & Nephew, Inc..

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Recall Summary

Total Recalls

66

Past Year

2

Class I (Serious)

0

Most Recent

Nov 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 21–40 of 66 recalls

Smith & Nephew, Inc.: smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, L, ...

Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponents reports were erroneous. Erroneous data from the reports was incorporated in the released IFU 81110294 EVOS Large Fragment Plating System.

FDANov 1, 2021Nationwide• Smith & Nephew, Inc.

Smith & Nephew, Inc.: Smith and Nephew EVOS Self-Tapping Locking Screw SST: (1...

The labels on the packages of screws were switched.

FDAOct 25, 2021AL, AZ, CA +22 more• Smith & Nephew, Inc.

Smith & Nephew, Inc.: Genesis (GII) - Product Usage: designed for use in patien...

The anterior locking detail does not meet its design specifications.

FDASep 21, 2020Nationwide

Page 2 of 4Next

• Smith & Nephew, Inc.

Smith & Nephew, Inc.: MICRORAPTOR REGENESORB SUTURE ANCHOR- Absorbable Suture a...

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

FDASep 9, 2020Nationwide• Smith & Nephew, Inc.

Smith & Nephew, Inc.: TWINFIX ULTRA PLLA HA 5.5MM W/ NEEDLES- Absorbable Suture...

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

FDASep 9, 2020Nationwide• Smith & Nephew, Inc.

Smith & Nephew, Inc.: TWINFIX ULTRA PLLA HA 6.5MM W/ NEEDLES- Absorbable Suture...

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

FDASep 9, 2020Nationwide• Smith & Nephew, Inc.

Smith & Nephew, Inc.: TWINFIX ULTRA HA 4.5 W/2 UB BLUE & BLK- Absorbable Suture...

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

FDASep 9, 2020Nationwide• Smith & Nephew, Inc.

Smith & Nephew, Inc.: TWINFIX ULTRA HA 5.5 W/2 UB BLUE & BLK- Absorbable Suture...

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

FDASep 9, 2020Nationwide• Smith & Nephew, Inc.

Smith & Nephew, Inc.: TWINFIX ULTRA HA 6.5 W/2 UB (BLUE & BLK)- Absorbable Sutu...

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

FDASep 9, 2020Nationwide• Smith & Nephew, Inc.

Smith & Nephew, Inc.: OSTEORAPTOR CRVD 2.3 SA UB COBRD BLUE- Absorbable Suture ...

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

FDASep 9, 2020Nationwide• Smith & Nephew, Inc.

Smith & Nephew, Inc.: HEALICOIL RG SA 5.5MM W/2 UB-BL CBR BL-- Absorbable Sutur...

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

FDASep 9, 2020Nationwide• Smith & Nephew, Inc.

Smith & Nephew, Inc.: HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL- Absorbable Sutu...

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

FDASep 9, 2020Nationwide• Smith & Nephew, Inc.

Smith & Nephew, Inc.: TWINFIX AB 5.0 SUTR ANCHR W/2 38 ULTRA-Absorbable Suture ...

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

FDASep 9, 2020Nationwide• Smith & Nephew, Inc.

Smith & Nephew, Inc.: TWINFIX 6.5MM AB PRELOADED SUTURE ANCHOR- Absorbable Sutu...

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

FDASep 9, 2020Nationwide• Smith & Nephew, Inc.

Smith & Nephew, Inc.: TWINFIX ULTRA 5.5MM PLLA/HA 2 UBWHT/BL--Absorbable Suture...

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

FDASep 9, 2020Nationwide• Smith & Nephew, Inc.

Smith & Nephew, Inc.: TWINFIX 6.5MM AB PRELOADED ULTRABRAID- Absorbable Suture ...

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

FDASep 9, 2020Nationwide• Smith & Nephew, Inc.

Smith & Nephew, Inc.: ULTRA FAST-FIX AB ASSEMBLY-REVERSE CURVE-Absorbable Sutur...

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

FDASep 9, 2020Nationwide• Smith & Nephew, Inc.

Smith & Nephew, Inc.: OSTEORAPTOR 2.3 W/ 1 UB COBRAID BLACK-Absorbable Suture a...

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

FDASep 9, 2020Nationwide• Smith & Nephew, Inc.

Smith & Nephew, Inc.: OSTEORAPTOR 2.3 W. UB COBRAID BLUE-Absorbable Suture anch...

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

FDASep 9, 2020Nationwide• Smith & Nephew, Inc.

Smith & Nephew, Inc.: OSTEORAPTOR 2.9 W/ 2 UB WHITE / BLUE -Absorbable Suture a...

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

FDASep 9, 2020Nationwide• Smith & Nephew, Inc.