FDA Device recall Z-0431-2021
Stryker Zyphr Disposable Cranial Perforator, Large 14/11 mm- is a sterile, single use cutting accessory intended for cutting an 11 mm diame…
- FDA Device
- Class II
- terminated
- Published 2020-11-18
On 2020-11-18 the FDA classified a Class II recall of Stryker Zyphr Disposable Cranial Perforator, Large 14/11 mm- is a sterile, single use cutting accessory intended for cutting an 11 mm diame… by Stryker Instruments Div, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0431-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-10-16 |
| Published | 2020-11-18 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Stryker Instruments Div |
| Distribution | US |
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
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.
Identifiers
| code_info | GTIN: 04546540716224 Lot Numbers: 20029027 20030077 20030087 20031017 20031027 20034017 20035017 20035027 200…GTIN: 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 20062037 20062047 20063017 20063027 20064017 20066017 20066027 20066037 20066047 20069017 20069027 20071017 20071027 20072017 20079017 20079027 20080017 20083017 20083027 20084017 20084027 20084037 20084047 20084057 20094017 20094027 20094037 20094047 20099017 20099027 20099037 20101017 20101027 20101037 20101047 20101057 20101067 20101077 20106027 20106047 20106087 20106107 20106117 20106127 20106137 20107017 20107027 20107037 20107047 20107057 20108017 20108027 20108037 20108047 20108057 20108067 2011 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0431-2021%22
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