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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot numbers: 15077027, 15077067, 15077097, 15078087, 15105017, 15108017, 15108047, 15108077, 15108087, 15108097, 15146017, 15146027, 15146037, 15146047
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Stryker Instruments Div. of Stryker Corporation
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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.
Product Codes/Lot Numbers:
Lot numbers: 15077027, 15077067, 15077097, 15078087, 15105017, 15108017, 15108047, 15108077, 15108087, 15108097, 15146017, 15146027, 15146037, 15146047
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2238-2016
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