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. The hazard is a potential packaging compromise after a specific time period, which is a precautionary measure without reported injuries or illnesses in the source text.
Plain-English summary
Stryker Leibinger GmbH & Co. KG is recalling 22,831 units of AXS PP, 3 X 2-Hole Plates with Tab, 1.5X4mm Self Drilling Screws (Part Number 12-01541S). These medical devices are 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 packaging issue could affect the sterility of the devices.
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 are listed in the source metadata. Healthcare providers and facilities should check their inventory for these specific part numbers and codes.
The recalled product
- Product
- AXS PP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING 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 (20)
- 1000201620
- 1000203741
- 1000215161
- 1000221838
- 1000224226
- 1000230171
- 1000232403
- 1000233774
- 1000235432
- 1000236133
- 1000238416
- 1000245179
- 1000251379
- 1000254404
- 1000255711
- 1000257449
- 1000258651
- 1000258652
- 1000259409
- 1000260283
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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