Reported Jul 27, 2016 · Terminated
2.3MM Tapered Router, Product Number 5407-FA2-023 A router is a cutting accessory used in the following medical…
Stryker Instruments Div. of Stryker Corporation
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 Div. of Stryker Corporation · 4100 E Milham Ave · Portage, MI · 49002-9704
Is this the product you have?
- 2.3MM Tapered Router, Product Number 5407-FA2-023 A router is a cutting accessory used
- in the following medical applicationsNeuro; Spine; Ear, Nose, and Throat (ENT)/Otology /Neurotology/ Otorhinolaryngology; Craniofacial (bones of the skull and supraorbital region); and Sternotomy. They are intended to be used with the Stryker CORE" system
- Lot codes and dates
- Lot numbers
1507702715077067150770971507808715105017151080171510804715108077151080871510809715146017151460271514603715146047
- Lot numbers
- Amount recalled
- 3,163
Where it was sold
- Nationwide
Why it was recalled
A variation in flute depth on the routers was observed. The variation in flute depth may cause the routers to be more susceptible to breakages. Risk to Health: Injury to critical soft tissue requiring surgical intervention may occur.
This product could cause temporary or reversible health problems — stop using it.
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