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, but the source text describes a potential packaging compromise without reporting any specific illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Stryker Leibinger GmbH & Co. KG is recalling QUIKFLAP 1x20mm Burr Hole Covers, 2 x 2-hole plates, and 1.5x4mm self-drilling screws (Part Number 12-01536S). These medical devices are used on the cranium.
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. This could affect the sterility of the device.
The recall involves 22,831 units. Distribution included the United States (AZ, FL, NH, and OH), Australia, Canada, France, New Zealand, and the UK. Healthcare providers should check their inventory for the affected lot codes 1000232402 and 1000237513 and stop using these products.
The recalled product
- Product
- QUIKFLAP, 1X20MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01536S, for use on the cranium
- Manufacturer
- Stryker Leibinger GmbH & Co. KG
- Hazard
- 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 (2)
- 1000232402
- 1000237513
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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