FDAMay 31, 2016device

Part # 313.212, 1.3mm Stardrive Screwdriver Bld Slf-Retain Med/60mm MQC, Lot # 4363780, mfg. 9/18/2002 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.

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

The hazard

DePuy Synthes is voluntarily initiating this recall due to affected devices that were distributed, etched and or labeled with MR Safety information not meeting the current ASTM standard.

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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