Stryker QUIKFLAP Cranium Plates Recalled for Packaging Compromise
Stryker is recalling QUIKFLAP cranium plates because the sterile packaging may become compromised after three years.
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, but the source text describes a potential packaging compromise without reporting any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity 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 12-01522S, which are used 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 could affect the sterility of the medical devices.
Healthcare providers and facilities should check their inventory for the specific part number and lot codes listed in the recall notice. If the devices are found, they should be removed from use and returned to Stryker according to the company's instructions.
The recalled product
- Product
- QUIKFLAP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01522S, 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)
- 1000096159
- 1000096935
- 1000096936
- 1000097334
- 1000097915
- 1000101820
- 1000109424
- 1000115216
- 1000119029
- 1000125079
- 1000125080
- 1000130030
- 1000136426
- 1000141584
- 1000147073
- 1000151497
- 1000156030
- 1000157137
- 1000162227
- 1000163908
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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