FDAFDA · Food and drugs·Recall number Z-2902-2018
QUIKFLAP, 1X20MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01526S, 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
- 1000213465, 1000239652, 1000245174, 1000255707
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Germany
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