Stryker Zyphr Disposable Cranial Perforator Recall: Crack Risk During Surgery
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.
Use caution until it’s fixed
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.
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/64089-stryker-zyphr-disposable-cranial-perforator-recall-crack-risk-during-surgery.
Source Summary by GovInfoNow · govinfonow.com/recall/64089-stryker-zyphr-disposable-cranial-perforator-recall-crack-risk-during-surgery · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0431-2021
Cite this page
“Stryker Zyphr Disposable Cranial Perforator Recall: Crack Risk During Surgery.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64089-stryker-zyphr-disposable-cranial-perforator-recall-crack-risk-during-surgery. Based on FDA recall #Z-0431-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0431-2021%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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.).
- Brand
Stryker- Product
Stryker Zyphr Disposable Cranial Perforator, Large 14/11 mm- is a sterile, single use cutting accessory intended for- Category
Medical device
What to do — step by step
Check Product Lot Number
Look for the specific lot numbers listed in the recall (e.g., 20029027, 20030077, etc.) on the device packaging or label.
Stop Using if Recalled
If you have the recalled product with a listed lot number, stop using it immediately and contact Stryker for further instructions.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Nationwide Foreign: Australia Brazil Canada Chile Colombia Hong Kong Italy Mexico Netherlands Netherlands New Zealand South Africa South Korea Spain Sweden Switzerland United Kingdom” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 20 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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.
- Official source: FDA Recall #Z-0431-2021 (October 16, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0431-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.