Device product
Stryker 2.3mm Tapered Router, Catalog no. 5820-071-023 instrument used in craniotomy procedures.
Z-1478-2022
Product summary
- Event
- Event 90535
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 543
- Official record key
device-enforcement:Z-1478-2022
Official wording
Reason: 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.
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.
Derived failure modes
-
Foreign material or chemical contamination
metal fragments