Recall Z-1809-2021 · KWQ Appliance, Fixation, Spinal Intervertebral Body
Alphatec Spine, Inc.
Atec Insignia Anterior Cervical Plate System, REF 136-0236 Insignia, ACP, 2-Level, 36 mm, Rx Only, Non-Sterile, UDI: (01)00190376268385
| Date | Apr 26, 2021 |
| Status | Terminated |
| Reason | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. |
| Root cause | Under Investigation by firm |
| Action | Between the dates of 4/27-28/2021, Alphatec Spine, Inc., distributed a "Urgent-Medical Device Recall Notification" . The notification was distributed via FedEx and E-Mail. In addition to informing consignees about the recall, Alphatec Spine Inc. asked customers to take the following actions: 1. Please promptly review your inventory to determine if any of the affected product listed above is within your possession. 2. Please abstain from sale and/or use and contact Alphatec Spine Customer Service for instructions on how to carry out a product return. All shipping instructions will be provide |
| Quantity | 18 units |
| Distribution | US Nationwide distribution in the states of FL, CA, IL, OK, TX, CT, IN, NC, WA, HI, ID, MA, SC, NM, and NY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K200995 | Insignia Anterior Cervical Plate System Alphatec Spine, Inc., May 21, 2020 |