Stryker QUIKFLAP Cranial Plates Recalled for Sterile Barrier Compromise
Stryker is recalling QUIKFLAP cranial plates because the sterile packaging may become compromised after three years, potentially affecting sterility.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard is a potential sterile barrier compromise without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Stryker Leibinger GmbH & Co. KG is recalling QUIKFLAP, 3 X 2-Hole Plates with Tab, 1.5X4mm Self Drilling Screws (Part Number 12-01532S). These medical devices are designed for use on the cranium. The recall involves 22,831 units distributed in the United States (AZ, FL, NH, OH), Australia, Canada, France, New Zealand, and the UK.
The recall is being conducted because there is a potential for the external packaging, which serves as the sterile barrier, to become compromised after a three-year term. This compromise could affect the sterility of the device.
Healthcare facilities and distributors should stop using the affected products and contact Stryker for further instructions. Consumers should not use these products if they have them in their possession.
The recalled product
- Product
- QUIKFLAP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01532S, for use on the cranium
- Manufacturer
- Stryker Leibinger GmbH & Co. KG
- Affected units
- 22,831
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 1000100540
- 1000100541
- 1000101992
- 1000101994
- 1000103661
- 1000110486
- 1000113766
- 1000115217
- 1000115218
- 1000131912
- 1000147952
- 1000157990
- 1000159893
- 1000164241
- 1000165529
- 1000170706
- 1000173343
- 1000175688
- 1000179042
- 1000179720
Distribution
Part of a larger recall action
This product is one of 18 recalled by Stryker Leibinger GmbH & Co. KG under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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