Recall Z-1878-2017 ยท KWQ Appliance, Fixation, Spinal Intervertebral Body
Ulrich Medical USA Inc
uNion Cervical Plate System Product Usage: The uNion Cervical Plate System is intended for anterior fixation of the cervical spine (C2 to Ti). The system is to be used to provide stabilization of the anterior cervical spine as an adjunct to fusion for the treatment of degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and ra
| Date | Apr 26, 2017 (initiated Mar 7, 2017) |
| Status | Terminated |
| Reason | Surgical technique was revised to prevent static plate screws blocking mechanisms from disassociating. |
| Root cause | Use error |
| Action | On March 7, 2017, the recalling firm sent letters by mail informing customers of the field correction along with the updated surgical technique which contains the enhanced cautionary statement. Customers were instructed to destroy older versions of the surgical technique. The letters also contained a link to the recalling firm's website on which the recalling firm posted the current, updated copy of the surgical technique. |
| Quantity | 4,854 plates |
| Distribution | US Nationwide in the states of: AL, AR, AZ, CA, CT, FL, GA, ID, IL, KS, LA, MO, MS, NY, OH, OK, OR, TN, TX, and WI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K150666 | uNion Cervical Plate System Ulrich Medical USA, Jun 22, 2015 |