Stryker recalls AXS PP Burr Hole Covers due to potential sterile packaging compromise after three years. Affected items include specific part numbers for cranium surgery use.
After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
Stryker is recalling AXS PP Burr Hole Covers that may have compromised sterile packaging after three years of use. This could lead to infection risks during surgical procedures.
The sterile packaging may become compromised after three years, potentially exposing the surgical components to contaminants. This could lead to infection during procedures if the packaging is no longer intact.
Surgical teams using these components for cranium procedures. Patients undergoing surgery with these parts are at risk of infection if the packaging is compromised.
Check for part numbers 1000201635, 1000215162, 1000230807, 1000236134, 1000253512, 1000256558, 1000258653, 1000260286, 1000263503, 1000261692, 1000265425, or 1000265426. These parts are used in cranium surgery.
Inspect the external sterile packaging for signs of compromise after three years of use.
The recall is due to potential compromise of the sterile packaging after three years of use, which could lead to infection risks during surgical procedures.
Affected part numbers include 1000201635, 1000215162, 1000230807, 1000236134, 1000253512, 1000256558, 1000258653, 1000260286, 1000263503, 1000261692, 1000265425, and 1000265426.
The sterile packaging is expected to remain intact for up to three years of use before potential compromise occurs.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-2913-2018 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-2913-2018 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.
