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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Stryker Leibinger GmbH & Co. KG is recalling AXS PP, 1X14MM Burr Hole Covers with 1.5X4mm Self Drilling Screws (Part Number 12-01548S). These medical devices are used on the cranium. 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.
The recall is 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 compromise could affect the sterility of the device. The agency has classified this as a Class II recall.
Healthcare facilities and consumers who have these specific lot numbers should stop using the product and contact Stryker for instructions on return or replacement. The affected lot codes are: 1000201577, 1000215164, 1000218602, 1000248070, 1000254405, 1000261028, 1000262520, 1000264409, 1000266168, 1000288211, 1000289258, and 1000292117.
The recalled product
- Product
- AXS PP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01548S, 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)
- 1000201577
- 1000215164
- 1000218602
- 1000248070
- 1000254405
- 1000261028
- 1000262520
- 1000264409
- 1000266168
- 1000288211
- 1000289258
- 1000292117
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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