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FDAJanuary 8, 2021device

Universal Femoral Sleeves - Product Usage: used primarily in revision surgeries with the S-ROM Noiles, LPS, SIGMA, and LCS Knee products.

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

The hazard

The taper dimensions may be out of specification due to a production issue during the manufacturing of these lots.

What to do

FDA enforcement status: Terminated

Brands named

depuy orthopaedicsdepuy

Recall history

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

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Universal Femoral Sleeves - Product Usage: used primarily in revision surgeries with the S-ROM Noiles, LPS, SIGMA, and LCS Knee products. — Recall Details · AllClear