Stryker recalls QUIKFLAP cranium plates with part number 12-01530S due to potential packaging compromise after three years. Affected units include specific serial numbers listed in the recall notice.
After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
Stryker is recalling QUIKFLAP cranium plates that may have compromised sterile packaging after three years. This could lead to infection or contamination if the plates are used without proper sterility.
After three years, the external sterile packaging may become damaged, potentially allowing contamination. This could lead to infection or improper sterility during surgery if the plates are used without the protective barrier.
Surgical teams and medical professionals who use these plates for cranium procedures. Patients undergoing surgery with these plates are at risk if the packaging becomes compromised.
Check for part number 12-01530S on the packaging. Affected units include specific serial numbers listed in the recall notice (e.g., 1000107793, 1000107794, etc.).
Inspect the external sterile packaging for signs of damage or compromise.
The recall is due to a potential compromise of the external sterile packaging after three years of use, which could lead to contamination.
Look for part number 12-01530S and check the serial numbers listed in the recall notice (e.g., 1000107793, 1000107794, etc.).
No immediate stop is required, but you should check the packaging for damage before use.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-2904-2018 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-2904-2018 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.
