Z-2238-2016 Class II Terminated
FDA device recall Z-2238-2016 was initiated by Stryker Instruments Div. Of Stryker Corporation on Jun 24, 2016 and is designated Class II. 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… The recall status is terminated (terminated Mar 23, 2017). Affected quantity: 3,163.
Recall details
- Product Type
- Devices
- Report Date
- Jul 27, 2016
- Initiation Date
- Jun 24, 2016
- Termination Date
- Mar 23, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,163
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.
Distribution pattern
Worldwide Distribution - US (Nationwide) Netherlands, Canada, Japan, Switzerland, and United Kingdom
Code information
Lot numbers: 15077027, 15077067, 15077097, 15078087, 15105017, 15108017, 15108047, 15108077, 15108087, 15108097, 15146017, 15146027, 15146037, 15146047
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2238-2016
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026