Reported Aug 3, 2022 · Ongoing
Stryker 2.3mm Tapered Router, Catalog no. 5820-071-023 instrument used in craniotomy procedures.
Stryker Instruments
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Stryker Instruments · 1941 Stryker Way · Portage, MI · 49002
Is this the product you have?
- Stryker 2.3mm Tapered Router, Catalog no. 5820-071-023 instrument used in craniotomy procedures.
- Lot codes and dates
- UDI-DI (GTIN)07613327294910
- Affected Lots22011017 21330017 20216017 20140017 20139027
- Amount recalled
- 543
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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