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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 41–60 of 66 recalls

Smith & Nephew, Inc.: TWINFIX ULTRA 6.5MM 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.: ULTRA FAST-FIX AB ASSEMBLY - STRAIGHT-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.: ULTRA FAST-FIX AB ASSEMBLY - CURVED-Absorbable Suture anc...

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

Page 3 of 4Next

FDA

Sep 9, 2020

Nationwide

• Smith & Nephew, Inc.

Smith & Nephew, Inc.: TWINFIX 5.0MM AB SUTURE ANCHOR WITH TWO 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 2.9 W/ 1 UB COBRAID 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.

Smith & Nephew, Inc.: HEALICOIL RG SA 5.5MM W/3 UB-BL CB BL BK- 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.: HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB 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.: BIORAPTOR 2.9MM SUTURE ANCHOR-Absorbable Suture anchor Pr...

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.: RAPTORMITE 3.7MM AB W/ NEEDLES AND TWO-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 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.: OSTEORAPTOR 2.9 W 1UB II BLUE--Absorbable Suture anchor P...

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 5.5 W/3 UB-Absorbable Suture anchor...

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 6.5 W/3 UB- Absorbable Suture ancho...

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 4.5MM 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.: Single RIKKI Retractor, Catalog #71934609 - Product Usage...

The products were improperly heat treated.

FDAAug 3, 2020CA, CO, CT +15 more• Smith & Nephew, Inc.

Smith & Nephew, Inc.: Tibial knee prosthesis

Due to an inconsistency in the raw material process, specific lots may contain units with internal non-homogenous material defects.

FDAJul 16, 2020AL, AZ, AR +22 more• Smith & Nephew, Inc.

Smith & Nephew, Inc.: Smith & Nephew T-F1X0 RCG Drill Pac, 2 mm Drill & (2) Sle...

The T-Fix sterile package contains only one sleeve instead of two, The device will not perform as intended for the second bone tunnel due to the absence of thesleeve

FDAJun 24, 2020Nationwide• Smith & Nephew, Inc.

Smith & Nephew, Inc.: SUTUREFIX ULTRA Suture, Product number 72203855

A packaging error resulted in a XL drill being presented for use instead of the S drill. The XL drill is one inch longer than the S drill.

FDAJun 24, 2020AL, AZ, AR +20 more• Smith & Nephew, Inc.

Smith & Nephew, Inc.: smith&nephew R3 THREE HOLE HA COATED HEMISPHERICAL STIKTI...

A manufacturing error resulted in out of specification R3 Acetabular Shells

FDAApr 22, 2020Nationwide• Smith & Nephew, Inc.

Smith & Nephew, Inc.: smith&nephew R3 NO HOLE HEMISPHERICAL STIKTITE COATED SHE...

A manufacturing error resulted in out of specification R3 Acetabular Shells

FDAApr 22, 2020Nationwide• Smith & Nephew, Inc.