Stryker recalls AXS PP burr hole covers with potential packaging compromise after three years. Affected items include specific part numbers for cranium use. Consumers should check if their product matches the listed serials.
After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
Stryker is recalling certain burr hole covers used in cranium procedures due to a risk that the sterile packaging could become compromised after three years. This could lead to contamination of the surgical site if the packaging fails.
After three years, the external sterile packaging might become compromised, potentially allowing contamination of the surgical site. This could lead to infection or other complications if the packaging fails during use.
Medical professionals using these components in cranium procedures are most at risk. Patients receiving these devices during surgery may be affected if the packaging fails.
Check for part number 12-01546S on the packaging. The affected items were sold with serial numbers including 1000201581, 1000215163, and other listed numbers.
Look for the part number 12-01546S on the packaging or check the serial numbers listed in the recall notice.
The product is safe for use if the packaging remains intact. However, after three years, there is a potential for the packaging to become compromised.
Check for part number 12-01546S and serial numbers listed in the recall notice, such as 1000201581 or 1000215163.
The recall does not specify a remedy, so contact Stryker directly to determine next steps.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-2914-2018 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-2914-2018 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.
