Stryker Craniotomy Router May Break and Leave Metal Fragments
Stryker 2.3mm Tapered Router (craniotomy instrument) may break due to undersized core, leaving metal fragments in the surgical site. This risks damage to critical brain structures or need for additional surgery.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with no reported injuries or illnesses. However, the potential hazard of metal fragments in a critical surgical site involving neurological and vascular structures qualifies as a high-risk scenario.
Plain-English summary
Stryker Instruments is recalling the Stryker 2.3mm Tapered Router (Catalog no. 5820-071-023), a surgical instrument used in craniotomy procedures (brain surgery). A total of 543 units have been distributed to facilities worldwide.
The instruments may have an undersized core diameter, which can cause the router to break during surgical use. When the tool breaks, metal fragments may remain in the surgical site where they could be inadvertently left behind.
These fragments pose a potential for additional surgical intervention to retrieve them, or could result in damage to critical neurological or vascular structures in the brain or surrounding tissue.
The recalled instruments were distributed to hospitals and surgical centers in Arizona, California, Florida, Georgia, Iowa, Michigan, Missouri, New Mexico, North Carolina, Ohio, Texas, Virginia, Canada, Netherlands, and Thailand. Affected lot numbers are: 22011017, 21330017, 20216017, 20140017, and 20139027. Healthcare facilities that have these instruments should stop using them and contact Stryker Instruments for replacement or return procedures.
The recalled product
- Product
- Stryker 2.3mm Tapered Router, Catalog no. 5820-071-023 instrument used in craniotomy procedures.
- Manufacturer
- Stryker Instruments
- Hazard
- metal-fragments
- device-breakage
- surgical-site-contamination
- neurological-damage-risk
Distribution
Distributed nationwide across the United States.
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