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, 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. The hazard is a potential sterile barrier compromise, which is a low-risk contamination issue without reported illnesses or injuries, fitting the Moderate severity criteria.
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 12-01526S). These medical devices are used on the cranium. The recall involves 22,831 units.
The recall is being conducted because there is a potential for the external packaging, which serves as a sterile barrier, to become compromised after a three-year term. This compromise could affect the sterility of the devices.
The affected units were distributed in the United States (Arizona, Florida, New Hampshire, and Ohio), Australia, Canada, France, New Zealand, and the UK. Affected lot codes include 1000213465, 1000239652, 1000245174, and 1000255707. Healthcare providers and facilities should check their inventory for these specific part numbers and lot codes and stop using the affected devices.
The recalled product
- Product
- QUIKFLAP, 1X20MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01526S, 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 (4)
- 1000213465
- 1000239652
- 1000245174
- 1000255707
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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