Stryker Instruments: Medical Device Recall in 2022 - (Recall #: Z-1478-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: June 24, 2022

Date Posted: August 3, 2022

Recall Number: Z-1478-2022

Event ID: 90535

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.

Status: Ongoing

Product Quantity: 543

Code Information:

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

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.

Voluntary or Mandated:

Voluntary: Firm initiated