Reported Sep 5, 2018 · Terminated

AXS PP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01541S, 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 PLATES WITH TAB
    • 1.5X4mm SELF DRILLING SCREWS
    • Part Number 12-01541S
    • for use on the cranium
Lot codes and dates
  • 61 of 61 codes

    • 1000201620
    • 1000203741
    • 1000215161
    • 1000221838
    • 1000224226
    • 1000230171
    • 1000232403
    • 1000233774
    • 1000235432
    • 1000236133
    • 1000238416
    • 1000245179
    • 1000251379
    • 1000254404
    • 1000255711
    • 1000257449
    • 1000258651
    • 1000258652
    • 1000259409
    • 1000260283
    • 1000260284
    • 1000260285
    • 1000261025
    • 1000261026
    • 1000261689
    • 1000261690
    • 1000261691
    • 1000263498
    • 1000263499
    • 1000263500
    • 1000263501
    • 1000263502
    • 1000264407
    • 1000264408
    • 1000265423
    • 1000265424
    • 1000266165
    • 1000266166
    • 1000266167
    • 1000267009
    • 1000267010
    • 1000267748
    • 1000267749
    • 1000267750
    • 1000268573
    • 1000268574
    • 1000269518
    • 1000269519
    • 1000270162
    • 1000270163
    • 1000270837
    • 1000270838
    • 1000285715
    • 1000287395
    • 1000289257
    • 1000201620
    • 1000288210
    • 1000290246
    • 1000291275
    • 1000292116
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, 4:46 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.