FDAMay 28, 2015device

Pull Reduction Device For 4.3mm Percutaneous Drill Guide; The pull reduction device with quick coupling is placed through the guide sleeve and plate holes to pull or push bone fragments relative to the plate. This instrument can be used for: Minor Varus-valgus adjustments (approximately 2¿ - 4¿),...

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

The hazard

Certain affected parts and lots of the Pull Reduction Devices may have been manufactured to an incorrect hardness specification which could result in intraoperative breakage.

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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