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

Company

Stryker Instruments

Recall Initiated

June 24, 2022

Recall Number

Z-1478-2022

Quantity

543

Firm Location

Portage, MI

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

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.

Lot / Code Info

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

Root Cause

Process change control

Action Taken

On June 24, 2022, the firm notified customers via Urgent Medical Device Recall Letters. Customers were instructed to locate and quarantine any affected products found in their inventory. Upon receiving the customer's completed response form, the firm will provide a shipping label to return any recalled product. Upon receipt of the recalled product, Stryker will contact the customer to arrange for replacement product.