Stryker AXS PP Burr Hole Cover Recall for Packaging Compromise
Stryker is recalling AXS PP 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. The hazard is a potential sterile barrier compromise after a specific time period, which is a precautionary issue without reported injuries or illnesses in the source text.
Plain-English summary
Stryker Leibinger GmbH & Co. KG is recalling AXS PP, 1X14MM Burr Hole Cover, 2 X 2-Hole Plates, 1.5X4mm Self Drilling Screws, Part Number 12-01544S. The product is intended 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 could affect the sterility of the device.
A total of 22,831 units are affected. Distribution includes the United States (AZ, FL, NH, and OH), Australia, Canada, France, New Zealand, and the UK. Healthcare providers should stop using the affected units and contact Stryker for further instructions.
The recalled product
- Product
- AXS PP, 1X14MM BURR HOLE COVER, 2 X 2-HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01544S, 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 (12)
- 1000201635
- 1000215162
- 1000230807
- 1000236134
- 1000253512
- 1000256558
- 1000258653
- 1000260286
- 1000263503
- 1000261692
- 1000265425
- 1000265426
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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