FDAMay 2, 2023device

Smith&Nephew ENGAGE Cementless Partial Knee System, Porous Femoral components, Part Numbers: a) REF 1-10003-100 (SIZE 1 Right Medial); b) REF 1-10003-110 (SIZE 1 Left Medial); c) REF 1-10003-200 (SIZE 2-Right Medial); d) REF 1-10003-210 (SIZE 2-Left Medial); e) REF 1-10003-300 (SIZE 3- Right Medi...

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

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UPCs

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Recall history

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

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