Recall Z-0431-2021— Stryker Instruments Div. of Stryker Corporation

Name: FDA recall Z-0431-2021
Creator: U.S. Food and Drug Administration
Published: 2020-10-16

Class II · Terminated

Class II FDA medical device recall by Stryker Instruments Div. of Stryker Corporation, initiated 2020-10-16, terminated 2022-06-22. It names one FDA 510(k) clearance: K082010. 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..

Recalling firm: Stryker Instruments Div. of Stryker Corporation
Classification: Class II
Status: Terminated
Initiated: 2020-10-16
Terminated: 2022-06-22
Firm location: Portage, MI, United States

510(k) clearances named in this recall

1 on FDA's record

K082010 — STRYKER DISPOSABLE CRANIAL PERFORATOR BITStryker Ireland Ltd., Instruments Division·cleared 2008-12-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.