Reported Sep 5, 2018 · Terminated

QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01520S The Stryker QuickFlap…

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 DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01520S The Stryker QuickFlap Sterile Procedure Pack is intended for reconstruction, stabilization and/or rigid fixation of non-load bearing bony areas subsequent to craniotomy, craniectomy and cranial fractures in adults and adolescents (age 12 and higher).
Lot codes and dates
    • 1000085083
    • 1000089303
    • 1000089990
    • 1000095193
    • 1000100539
    • 1000104523
    • 1000107792
    • 1000110518
    • 1000116215
    • 1000124115
    • 1000129492
    • 1000134144
    • 1000139985
    • 1000146194
    • 1000151496
    • 1000156358
    • 1000164801
    • 1000167015
    • 1000170704
    • 1000174837
    • 1000178195
    • 1000181123
    • 1000183608
    • 1000188543
    • 1000192851
    • 1000197301
    • 1000209029
    • 1000219395
    • 1000221066
    • 1000237512
    • 1000239649
    • 1000240995
    • 1000251376
    • 1000259411
    • 1000275865
    • 1000286361
    • 1000290245
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, 6:07 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.