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.
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, 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 22,831 units of AXS PP, 3 X 2-Hole Dog Bone Plates with 1.5x4mm Self Tapping Screws (Part Number 12-01541S). These medical devices are designed for use on the cranium.
The recall was initiated 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 (AZ, FL, NH, and OH), Australia, Canada, France, New Zealand, and the UK. Specific lot codes associated with this recall include 1000201582, 1000254804, 1000258650, 1000259408, 1000261022, 1000262518, and 1000262519. Healthcare providers should check their inventory for these specific part numbers and lot codes.
The recalled product
- Product
- AXS PP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01541S, 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 (7)
- 1000201582
- 1000254804
- 1000258650
- 1000259408
- 1000261022
- 1000262518
- 1000262519
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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