Stryker 2 recalled over possible metal fragments

Recall date

June 24, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

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

Recall number

Z-1478-2022

FDA classification

Class II

Brand / firm

Stryker Instruments

Sold / distributed

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.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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