Alphatec Spine, Inc. Recall 87887
Description: Atec Insignia Anterior Cervical Plate System, REF 136-0354 Insignia, ACP, 3-Level, 54 mm, Rx Only, Non-Sterile, UDI: (01)00190376268583
Alphatec Spine, Inc. Recall 87887 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1818-2021 |
| Event ID | 87887 |
| Event Description | Atec Insignia Anterior Cervical Plate System, REF 136-0354 Insignia, ACP, 3-Level, 54 mm, Rx Only, Non-Sterile, UDI: (01)00190376268583 |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of FL, CA, IL, OK, TX, CT, IN, NC, WA, HI, ID, MA, SC, NM, and NY. |
| Quantity | 7 units |
| Recall Reason | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. |
| Device Classification | 20210616 |
| Device Code Info | 8609324R |
| Center Classification Date | 20210607 |
| Recall Initiation Date | 20210426 |
| Recalling Firm | Alphatec Spine, Inc. |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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