Stryker recalls large 14/11 mm disposable cranial perforators due to potential cracks that could cause metal fragments in surgical sites or delayed disengagement. Affected units have specific lot numbers.
Potential for the inner bit to contain a crack, that may or may not be visible, which may lead to metal fragments entering the surgical site and/or delayed disengagment during use.
Stryker is recalling large disposable cranial perforators that may have cracks invisible to the eye. These cracks could cause metal fragments to enter surgical sites or cause the tool to not detach properly during surgery.
The inner bit of the perforator may have a crack that isn't visible. If the crack is present, metal fragments could enter the surgical site, or the tool might not detach from the cranium during use, potentially causing complications.
Surgical teams using the recalled Stryker Zyphr Disposable Cranial Perforator for adult cranium procedures. Patients undergoing surgery with this tool are at risk if the device has a crack.
Check for the product name 'Stryker Zyphr Disposable Cranial Perforator, Large 14/11 mm' with lot numbers listed in the recall (e.g., 20029027, 20030077, etc.).
Look for the specific lot numbers listed in the recall (e.g., 20029027, 20030077, etc.) on the device packaging or label.
If you have the recalled product with a listed lot number, stop using it immediately and contact Stryker for further instructions.
The recall states that the product may have cracks that could lead to metal fragments entering the surgical site or delayed disengagement during use. Affected units should not be used.
Check the lot number against the list provided in the recall. If it matches, stop using it immediately and contact Stryker for instructions.
Look for the specific lot numbers listed in the recall (e.g., 20029027, 20030077, etc.) on the device packaging or label.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-0431-2021 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-0431-2021 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.
