Reported Sep 5, 2018 · Terminated

QUIKFLAP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01532S, 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?

    • QUIKFLAP
    • 3 X 2-HOLE PLATES WITH TAB
    • 1.5X4mm SELF DRILLING SCREWS
    • Part Number 12-01532S
    • for use on the cranium
Lot codes and dates
    • 1000100540
    • 1000100541
    • 1000101992
    • 1000101994
    • 1000103661
    • 1000110486
    • 1000113766
    • 1000115217
    • 1000115218
    • 1000131912
    • 1000147952
    • 1000157990
    • 1000159893
    • 1000164241
    • 1000165529
    • 1000170706
    • 1000173343
    • 1000175688
    • 1000179042
    • 1000179720
    • 1000187363
    • 1000191064
    • 1000193587
    • 1000200400
    • 1000202174
    • 1000202430
    • 1000204636
    • 1000209030
    • 1000211804
    • 1000215160
    • 1000225770
    • 1000230169
    • 1000232401
    • 1000235430
    • 1000238413
    • 1000245177
    • 1000247183
    • 1000255708
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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jul 8, 2019 · Data as of Sep 19, 4:45 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.