Stryker recalls QUIKFLAP surgical covers (part 12-01534S) due to potential packaging compromise after 3 years. Affected units sold in 2021-2022; 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 QUIKFLAP surgical covers that may have compromised packaging after three years. This could lead to contamination of the sterile barrier, risking infection during surgery.
After three years, the external sterile packaging might become damaged, allowing contaminants to enter the sterile barrier. This could lead to infection during surgery if the covers are used without proper sterility.
Surgical teams using these QUIKFLAP covers for cranium procedures. Patients undergoing surgery with these covers are at risk of infection if the packaging is compromised.
Check for part number 12-01534S on the packaging. These covers were sold in 2021-2022 for cranium procedures. The product names include QUIKFLAP 1X14MM Burr Hole Cover, 2x2-Hole Plates, and 1.5x4mm Self Drilling Screws.
Look for the part number 12-01534S on the packaging to confirm if it's affected.
The external sterile packaging may become compromised after three years, risking contamination during surgery.
Check for part number 12-01534S on the packaging. These covers were sold in 2021-2022 for cranium procedures.
The recall record does not specify a remedy, so contact Stryker directly 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-2907-2018 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-2907-2018 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
