Reported Jul 20, 2016 · Terminated
Part # 313.946, Low Profile Neuro Screwdriver Blade/MR Safe/MQC/56mm Medium, Lot # 5053374, mfg 7/27/2005 Product…
Synthes (USA) Products LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Synthes (USA) Products LLC · 1301 Goshen Pkwy · West Chester, PA · 19380-5986
Is this the product you have?
- Part # 313.946, Low Profile Neuro Screwdriver Blade/MR Safe/MQC/56mm Medium, Lot # 5053374
- mfg 7/27/2005 Product UsageThe DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant
- Lot codes and dates
- Part # 313.946, Low Profile Neuro Screwdriver Blade/MR Safe/MQC/56mm Medium, Lot # 5053374, mfg 7/27/2005
- Amount recalled
- 26 units
This recall covers 18 products
The agency filed one notice per product. You are reading one of them; the other 17 are below.
5 more are in the archive.
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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