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FDAMay 2, 2023device

Smith&Nephew ENGAGE Cementless Partial Knee System, Tibial Anchor Stem, Part Numbers: a) REF 1-10011-100 (SIZE 1-2), b) REF 1-10011-200 (SIZE 3-4), c) REF 1-10011-300 (SIZE 5-6); Unicondylar knee prothesis

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Recent complaint data indicates that the revision rate may be trending higher than corresponding similar devices in global joint replacement registries. The data identifies a potential signal that the performance is an outlier versus the state of the art with respect to the risk for revision.

What to do

FDA enforcement status: Ongoing

Brands named

smith nephewsmithsmith nephew

UPCs

008855568730830088555687309000885556873106

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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Smith&Nephew ENGAGE Cementless Partial Knee System, Tibial Anchor Stem, Part Numbers: a) REF 1-10011-100 (SIZE 1-2), b) REF 1-10011-200 (SIZE 3-4), c) REF 1-10011-300 (SIZE 5-6); Unicondylar knee prothesis — Recall Details · AllClear