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FDAJuly 6, 2016device

SPHERICAL HEAD REFLECTION(R) 6.5 MM CANCELLOUS SCREW, REF 71332525, QTY: (1), STERILE R, smith&nephew Total hip components are indicated for individuals undergoing primary or revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or non...

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

The hazard

The labels correctly state that the product should be a 25mm screw, but the box contained a longer, 35mm screw.

What to do

FDA enforcement status: Terminated

Brands named

smith nephewsmithsmith nephew

Recall history

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

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