Reported Sep 5, 2018 · Terminated
AXS PP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01540S, 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 PP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01540S, for use on the cranium
- Lot codes and dates
100020151410002037401000216825100022016610002331951000237514100023841510002451781000252563100025418910002544031000255709100025655710002574481000258647100025864810002586491000259406100025940710002602811000260282100026102310002610241000261687100026168810002625151000262516100026251710002634971000264403100026440410002644051000265422100026857110002685721000201514100028739410002921151000293285
- 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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