FDA-Device2020-11-18Class II
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
Stryker Instruments Div. of Stryker Corporation
Hazard
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.
Sold states
Nationwide Foreign: Australia Brazil Canada Chile Colombia Hong Kong Italy Mexico Netherlands Netherlands New Zealand South Africa South Korea Spain Sweden Switzerland United Kingdom
Affected count
18,492 devices. Expanded Recall total: 18,594 devices
Manufactured in
4100 E Milham Ave, Portage, MI, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0431-2021Don't want to check this manually?
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