Stryker AXS PP Cranium Plates Recalled for Packaging Compromise
Stryker is recalling 22,831 AXS PP cranium plates because the sterile packaging may become compromised after three years.
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, and the hazard is a potential sterile barrier compromise without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Stryker Leibinger GmbH & Co. KG is recalling 22,831 units of AXS PP, 3 X 2-Hole Dog Bone Plates with 1.5x4mm Self Drilling Screws (Part Number 12-01540S). These medical devices are intended for use 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 compromise could affect the sterility of the device.
The affected products were distributed in the United States (Arizona, Florida, New Hampshire, and Ohio), Australia, Canada, France, New Zealand, and the United Kingdom. Specific lot codes are listed in the agency's recall record.
The recalled product
- Product
- AXS PP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01540S, 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 (20)
- 1000201514
- 1000203740
- 1000216825
- 1000220166
- 1000233195
- 1000237514
- 1000238415
- 1000245178
- 1000252563
- 1000254189
- 1000254403
- 1000255709
- 1000256557
- 1000257448
- 1000258647
- 1000258648
- 1000258649
- 1000259406
- 1000259407
- 1000260281
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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