Stryker recalls AXS PP cranium plates (part 12-01541S) due to potential sterile packaging compromise after three years. Affected units include specific serial numbers. Contact Stryker for details.
After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
Stryker is recalling cranium plates with a potential packaging compromise after three years. This could lead to contamination if the sterile barrier fails, but the risk is low for most users.
After three years, the sterile packaging could become compromised, potentially allowing contamination. This risk is specific to medical use and not a general hazard.
Medical professionals using these plates for cranium procedures are most at risk. Patients receiving these plates during surgery may also be affected.
Check for part number 12-01541S on the packaging. Affected units include serial numbers 1000201582, 1000254804, 1000258650, 1000259408, 1000261022, 1000262518, and 1000262519.
Look for the part number 12-01541S on the packaging to confirm if it's affected.
The sterile packaging may become compromised after three years, potentially leading to contamination during medical procedures.
Check for part number 12-01541S and serial numbers 1000201582, 1000254804, 1000258650, 1000259408, 1000261022, 1000262518, or 1000262519.
No, but if you have the recalled part number, contact Stryker for guidance.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-2911-2018 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-2911-2018 from Stryker. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
