FDAFDA · Food and drugs·Recall number Z-2912-2018
AXS PP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01541S, for use on the cranium
Published September 5, 2018 · Recall initiated: June 22, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Stryker Leibinger GmbH & Co. KG
- Distributor
- US distribution in the states: AZ, FL, NH, and OH, Australia, Canada, France, New Zealand, and UK.
- Lot
- 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, 1000294081
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Germany
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