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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

Past Year

Class I (Serious)

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 61–66 of 66 recalls

Smith & Nephew, Inc.: smith&nephew R3 ZERO HOLE HA COATED HEMISPHERICAL STIKTIT...

A manufacturing error resulted in out of specification R3 Acetabular Shells

Moderate

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

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

A manufacturing error resulted in out of specification R3 Acetabular Shells

Moderate

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

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

A manufacturing error resulted in out of specification R3 Acetabular Shells

Moderate

FDAApr 22, 2020Nationwide

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• Smith & Nephew, Inc.

Smith & Nephew, Inc.: smith&nephew R3 MULTI HOLE HEMISPHERICAL STIKTITE COATED ...

A manufacturing error resulted in out of specification R3 Acetabular Shells

Moderate

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

Smith & Nephew, Inc.: Smith & Nephew FOOTPRINT ULTRA PK SUTURE ANCHOR 4.5 Part...

Space between the device and the packaging permits excessive movement which could potentially lead to the displacement of the anchors tip protector allowing the tip of the anchor to create a sterile breach.

Moderate

FDAMar 17, 2020Nationwide• Smith & Nephew, Inc.

Smith & Nephew, Inc.: LEGION AP Cutting Block Size 4, REF 71434409; LEGION AP ...

Laceration Risk

Multiple lots of LEGION AP Femoral Cutting Blocks were manufactured with an oversize green plunger hole and therefore do not meet their design specifications.

Moderate

FDADec 16, 2019DE, IA, NC +2 more• Smith & Nephew, Inc.