Reported Sep 5, 2018 · Terminated
AXS PP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01548S, for use on the cranium
Stryker Leibinger GmbH & Co. KG
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: Stryker Leibinger GmbH & Co. KG · Botzinger Str. 41 · Freiburg Im Breisgau, N/A · N/A
Is this the product you have?
AXS PP1X14MM BURR HOLE COVER1.5X4mm SELF DRILLING SCREWSPart Number 12-01548Sfor use on the cranium
- Lot codes and dates
100020157710002151641000218602100024807010002544051000261028100026252010002644091000266168100028821110002892581000292117
- Amount recalled
- 22,831 total
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
After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
This product could cause temporary or reversible health problems — stop using it.
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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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