FDA recall Z-0431-2021

Stryker Instruments Div. of Stryker Corporation · Class II · device

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.

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

Key facts

Status: Terminated
Initiation date: 2020-10-16
Report date: 2020-11-18
Termination date: 2022-06-22
Voluntary/Mandated: Voluntary: Firm initiated
Location: Portage, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0431-2021