Stryker recalls QUIKFLAP cranium plates (part 12-01531S) due to potential sterile packaging compromise after three years. Affected units sold with specific serial numbers. Contact for return instructions.
After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
Stryker is recalling cranium plates that may have compromised sterile packaging after three years. This could lead to infection risks if the packaging fails during medical use.
The sterile packaging may become compromised after three years of storage. This could allow contamination of the surgical plates, increasing infection risk during medical procedures.
Medical professionals using these plates for cranium procedures are most at risk. Patients receiving these plates during surgery could be affected if the packaging fails.
Check for part number 12-01531S on the packaging. Affected units include serial numbers 1000181748 and 1000295062.
Look for the part number 12-01531S on the packaging to confirm if it's affected.
The sterile packaging may become compromised after three years, potentially increasing infection risk during medical procedures.
Check for part number 12-01531S and serial numbers 1000181748 or 1000295062 on the packaging.
The recall record does not specify a remedy, so contact Stryker directly for instructions.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-2905-2018 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-2905-2018 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.
