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FDAMay 2, 2023device

Smith&Nephew ENGAGE Cementless Partial Knee System, Coated Tibial Insert, Part Numbers: a) REF 1-10013-109, SIZE 1-LEFT MED, 9MM; b) REF 1-10013-110, SIZE 1-LEFT MED, 10MM; c) REF 1-10013-111, SIZE 1-LEFT MED, 11MM; d) REF 1-10013-113, SIZE 1-LEFT MED, 13MM; e) REF 1-10013-159, SIZE 1-RIGHT MED, ...

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

885556873236885556873243885556873250885556873267885556873274885556873281885556873298885556873304885556873311885556873328885556873335885556873342

Recall history

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

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