PlainRecalls
FDA Devices Moderate Class II Terminated

2.3MM Tapered Router, Product Number 5407-FA2-023 A router is a cutting accessory used in the following medical applications: Neuro; 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.

Reported: July 27, 2016 Initiated: June 24, 2016 #Z-2238-2016

Product Description

2.3MM Tapered Router, Product Number 5407-FA2-023 A router is a cutting accessory used in the following medical applications: Neuro; 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.

Reason for Recall

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.

Details

Units Affected
3,163
Distribution
Worldwide Distribution - US (Nationwide) Netherlands, Canada, Japan, Switzerland, and United Kingdom
Location
Portage, MI

Frequently Asked Questions

What product was recalled? ▼
2.3MM Tapered Router, Product Number 5407-FA2-023 A router is a cutting accessory used in the following medical applications: Neuro; 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.. Recalled by Stryker Instruments Div. of Stryker Corporation. Units affected: 3,163.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 27, 2016. Severity: Moderate. Recall number: Z-2238-2016.

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