Stryker QUIKFLAP Burr Hole Cover Recall Due to Packaging Compromise
Stryker is recalling QUIKFLAP burr hole covers 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, and the source text describes a potential for packaging compromise without reporting specific injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Stryker Leibinger GmbH & Co. KG is recalling the QUIKFLAP 1x14mm Burr Hole Cover, Part Number 12-01534S. This medical device is used on the cranium and includes 2-hole plates and self-drilling screws.
The recall is being issued because there is a potential for the external packaging, which serves as the sterile barrier, to become compromised after a three-year term. A compromised sterile barrier could affect the sterility of the device.
A total of 22,831 units are affected. Distribution included the United States (AZ, FL, NH, and OH), Australia, Canada, France, New Zealand, and the UK. Affected lot codes are 1000230170, 1000235431, and 1000265421. Healthcare providers should stop using the affected units and contact Stryker for instructions.
The recalled product
- Product
- QUIKFLAP, 1X14MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01534S, 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 (3)
- 1000230170
- 1000235431
- 1000265421
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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