Stryker recalls QUIKFLAP cranium surgical covers (part 12-01528S) due to potential sterile packaging compromise after three years. Affected units sold with specific serial numbers. Consumers should 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 surgical covers that may have compromised sterile packaging after three years of use. This could lead to infection risks if the packaging is no longer intact.
The sterile packaging may degrade over time, potentially allowing contaminants to enter the surgical site. This could increase infection risk during procedures.
Surgical teams and hospitals using the QUIKFLAP cranium covers. Patients undergoing surgery with these covers are at risk if the packaging becomes compromised.
Check for part number 12-01528S on the packaging. Affected units include specific serial numbers: 1000221067, 1000239653, 1000245175, 1000261686.
Inspect the sterile barrier packaging for signs of damage or compromise.
The sterile packaging may become compromised after three years of use, potentially increasing infection risk during surgery.
Check for part number 12-01528S and serial numbers 1000221067, 1000239653, 1000245175, or 1000261686.
Contact Stryker directly for instructions on how to handle the product.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-2903-2018 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-2903-2018 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.
