PlainRecalls
FDA Devices Moderate Class II Terminated

Part #313.221, 1.5mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC, lot # 4341033, 4589566, 4703774, 4363781, 4589567, 4793575, 4904305, 4427700,4589568, 4830581, 4532370, 4673943, 4871657, mfg. 2/12/2002-5/23/2005 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.

Reported: July 20, 2016 Initiated: May 31, 2016 #Z-2196-2016

Product Description

Part #313.221, 1.5mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC, lot # 4341033, 4589566, 4703774, 4363781, 4589567, 4793575, 4904305, 4427700,4589568, 4830581, 4532370, 4673943, 4871657, mfg. 2/12/2002-5/23/2005 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.

Reason for Recall

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.

Details

Units Affected
383 units
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.
Location
West Chester, PA

Frequently Asked Questions

What product was recalled? ▼
Part #313.221, 1.5mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC, lot # 4341033, 4589566, 4703774, 4363781, 4589567, 4793575, 4904305, 4427700,4589568, 4830581, 4532370, 4673943, 4871657, mfg. 2/12/2002-5/23/2005 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.. Recalled by Synthes (USA) Products LLC. Units affected: 383 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 20, 2016. Severity: Moderate. Recall number: Z-2196-2016.

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