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FDADecember 17, 2014device

CoCr Femoral Head - indicated for hip arthroplasty for noncemented use in skeletally mature invididuals undergoing primary surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease

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

The hazard

Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in surgery may result. If undetected breach in both the inner and outer trays were to occur, and there is contamination present, a periprosthetic infection is possible, which could lead to revision.

What to do

FDA enforcement status: Terminated

Brands named

zimmer

Recall history

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

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CoCr Femoral Head - indicated for hip arthroplasty for noncemented use in skeletally mature invididuals undergoing primary surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease — Recall Details · AllClear