Product Wiki · Recalls · U.S. FDA — Device Enforcement

Part # 313.250, 1.1mm Drill Bit, Mini QC with 4mm Stop/44.5mm — recall Z-2199-2016

U.S. FDA — Device Enforcement · United States · 2016-05-31 · Class II

As described by U.S. FDA — Device Enforcement: Part # 313.250, 1.1mm Drill Bit, Mini QC with 4mm Stop/44.5mm, lot # 4326989, mfg. 9/28/2001 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2199-2016
Date of alert
2016-05-31
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Synthes (USA) Products LLC
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
US Nationwide Distribution in the states of: AR,CA,CO,CT,DC,ID,IL,KY,LA,MA,MD,MN,MO,MS,MT,NY,PA and TX.
Reported risk: 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.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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