Reported Sep 5, 2018 · Terminated
QUIKFLAP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01522S, 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?
QUIKFLAP3 X 2-HOLE PLATES WITH TAB1.5X4mm SELF DRILLING SCREWSPart Number 12-01522Sfor use on the cranium
- Lot codes and dates
10000961591000096935100009693610000973341000097915100010182010001094241000115216100011902910001250791000125080100013003010001364261000141584100014707310001514971000156030100015713710001622271000163908100016701610001697511000176390100017819610001817471000184371100018659510001873621000191062100019358510001944761000199414100020566010002109371000211803100021262610002143351000222495100023319310002396501000247182100025655610002661641000270836100027710410002835901000287393100029408010000861931000298088
- 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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