FDANovember 11, 2019device

smith&nephew PROFIX Mallet, 750 GRAMS, REF 71512452 - Product Usage: The PROFIX Mallet is a reusable surgical instrument used to tap instruments or implants during knee or hip surgery.

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

The hazard

There is a a potential failure mode associated with the use of the mallet, wherein the poly tip of the mallet may become loose and/or come off during use. If the potential failure mode occurs, particles generated in the poly thread potentially could enter the surgical field or a delay in surgery could occur if the tip disengages during the use of the mallet.

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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