Home / Recalls / Stryker Instruments / Z-1478-2022

Z-1478-2022 Class II Ongoing

Recalled by Stryker Instruments — Portage, MI

Recall Details

Product Type: Devices
Report Date: August 3, 2022
Initiation Date: June 24, 2022
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 543

Product Description

Stryker 2.3mm Tapered Router, Catalog no. 5820-071-023 instrument used in craniotomy procedures.

Reason for Recall

There is a potential for the core diameter to be undersized, which may lead to the router breaking. A break can lead to unintended metal fragments in the surgical site, resulting in the potential for surgical intervention or damage to critical neurological or vascular structures.

Distribution Pattern

Worldwide distribution - US Nationwide distribution in the states of Arizona, California, Florida, Georgia, Iowa, Michigan, Missouri, New Mexico, North Carolina, Ohio, Texas, Virginia and the countries of Canada, Netherlands, and Thailand.

Code Information

UDI-DI (GTIN): 07613327294910 Affected Lots: 22011017 21330017 20216017 20140017 20139027