Stryker 2.3mm Tapered Router, Catalog no. 5820-071-023 instrument used in craniotomy procedures.
Check against the official notice below — it lists the full affected range.
Stryker is recalling 543 units of its 2.3mm Tapered Router (Catalog no. 5820-071-023), an instrument used in craniotomy procedures. The device has a potential defect where the core diameter may be undersized, which could cause the router to break during surgery. If the router breaks, metal fragments may remain in the surgical site, potentially requiring additional surgical intervention or causing damage to critical neurological or vascular structures.
The affected instruments were distributed worldwide, including to the United States in Arizona, California, Florida, Georgia, Iowa, Michigan, Missouri, New Mexico, North Carolina, Ohio, Texas, and Virginia, as well as to Canada, the Netherlands, and Thailand. The affected lot numbers are 22011017, 21330017, 20216017, 20140017, and 20139027. The source document does not specify a remedy or steps consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Quantity: 543 Lot/code info: UDI-DI (GTIN): 07613327294910 Affected Lots: 22011017 21330017 20216017 20140017 20139027
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.