Recall Z-2238-2016 ยท HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
Stryker Instruments Div. of Stryker Corporation
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.
| Date | Jul 19, 2016 (initiated Jun 24, 2016) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process design |
| Action | Stryker sent an Urgent Medical Device Recall Notification letter dated June 24, 2016, to the affected customers via courier, and to Sales Representatives and international affiliates via e-mail. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. For questions regarding this recall, please contact Stryker Instruments at 269-389-2921. |
| Quantity | 3,163 |
| Distribution | Worldwide Distribution - US (Nationwide) Netherlands, Canada, Japan, Switzerland, and United Kingdom |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K143399 | Stryker Footed Attachments and Cutting Accessories Stryker Corp., May 8, 2015 |