Stryker AXS PP Burr Hole Cover Recall Due to Packaging Compromise
Stryker is recalling AXS PP 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 compromise of the sterile barrier after a specific time period, which is a precautionary measure regarding sterility rather than a reported injury or high-risk pathogen.
Plain-English summary
Stryker Leibinger GmbH & Co. KG is recalling the AXS PP, 1X20MM BURR HOLE COVER, 2 X 2-HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01546S. This medical device is designed for use on the cranium.
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.
The recall involves 22,831 units distributed in the United States (AZ, FL, NH, OH) and internationally in Australia, Canada, France, New Zealand, and the UK. Affected lots include codes 1000201581, 1000215163, 1000230808, 1000252564, 1000256560, 1000259410, 1000260287, 1000263504, 1000211563, 1000267011, and 1000267751. Users should contact the manufacturer for instructions on how to proceed.
The recalled product
- Product
- AXS PP, 1X20MM BURR HOLE COVER, 2 X 2-HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01546S, 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 (11)
- 1000201581
- 1000215163
- 1000230808
- 1000252564
- 1000256560
- 1000259410
- 1000260287
- 1000263504
- 1000211563
- 1000267011
- 1000267751
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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