FDAOctober 6, 2015device

2.7 mm Locking Screw SLF-TPNG with T8 Stardrive Recess 12mm. The Synthes modular Mini Fragment LCP System is intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments.

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

The hazard

Specific lots of the SS 2.7mm locking screw have been mislabeled as SS 2.4mm locking screw.

What to do

FDA enforcement status: Terminated

Brands named

synthes usa productssynthessynthes usa

Recall history

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

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