Stryker Zyphr Disposable Cranial Perforator — Class II medical device recall Z-0431-2021
Terminated recall by Stryker Instruments Div. of Stryker Corporation, reported 2020-11-18, distributed nationwide. Potential for the inner bit to contain a crack, that may or may not be visible, which may lead to metal fragme
| Recall number | Z-0431-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Instruments Div. of Stryker Corporation, Portage, MI, United States |
| Recall initiated | 2020-10-16 |
| Classified | 2020-11-06 |
| Reported by FDA | 2020-11-18 |
| Terminated | 2022-06-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BR, CA, CH, CL, CO, ES, GB, HK, IT, KR, MX, NL, NZ, SE, ZA |
| Reason classes | foreign material, packaging |
| UPC / GTIN / UDI-DI | 04546540716224 |
| Lot numbers | 20029027, 20030077, 20030087, 20031017, 20031027, 20034017, 20035017, 20035027, 20035037, 20036017, 20036027, 20038017, 20038027, 20040027, 20041017, 20042017, 20044017, 20044027, 20047017, 20048017, 20048027, 20048037, 20051017, 20052017, 20052047, 20055017, 20055027, 20055037, 20055047, 20056017, 20057017, 20057037, 20058017, 20058027, 20059017, 20059027, 20059037, 20059047, 20062017, 20062027 and 200 more |
| Model numbers | 5100-060-001 |
Product
Stryker Zyphr Disposable Cranial Perforator, Large 14/11 mm- is a sterile, single use cutting accessory intended for cutting an 11 mm diameter access hole through the cranium of adult patients. Catalog Number: 5100-060-001
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0431-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.