Stryker recalls 3 X 2-hole cranium plates with self-drilling screws that may have compromised sterile packaging after three years of use. Consumers should check product serial numbers to determine if affected.
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 or contamination during surgery if the packaging is no longer intact.
The sterile packaging designed to protect the plates from contamination may weaken over time. If the packaging becomes compromised after three years, the plates could be exposed to bacteria or other contaminants during surgical procedures.
Medical professionals using these plates for cranium surgery are most at risk. Patients undergoing surgery with these specific plates may be affected if the packaging becomes compromised.
Check for the part number 12-01522S on the packaging. The product was sold with serial numbers listed in the recall notice, including 1000096159 through 1000298088.
Look for the part number 12-01522S and serial numbers listed in the recall notice.
The sterile packaging may become compromised after three years of use, potentially leading to contamination during surgery.
Check for the part number 12-01522S and serial numbers listed in the recall notice, including 1000096159 through 1000298088.
The recall 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-2900-2018 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-2900-2018 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.
