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FDAAugust 7, 2017device

LCP Drill Sleeve 1.5 Drill Bit 1.1mm Part Number 03.114.001 Used in LCP Modular Mini Fragment System, for fixation of small bones and small bone fragments

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

The hazard

May have difficulty attaching the drill sleeve to the plate. If the drill sleeve will not connect to the plate intraoperatively, surgical delay could occur. If the pilot hole is drilled without the drill sleeve, the pilot hole could be off-center which could result in screw and/or plate loosening.

What to do

FDA enforcement status: Terminated

Brands named

synthes

Recall history

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

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