medical Class II Updated 2022-08-03

Stryker Instruments recalls Stryker 2.3mm Tapered Router, Catalog no. 5820-071-023 instr

Recalled Product

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

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI-DI (GTIN): 07613327294910 Affected Lots: 22011017 21330017 20216017 20140017 20139027
View official government recall

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