Recall Z-0807-04 ยท KWQ Appliance, Fixation, Spinal Intervertebral Body
Spinal Concepts, Inc
One-level Ant-Cer Plates (Assembly Level). 1706-1024, 1706-1026, 1706-1028, 1706-1030, 1706-1032, and product literature. Devices are manufactured by Spinal Concepts, Inc., An Abbott Laboratories Company
| Date | Jul 20, 2004 (initiated Mar 1, 2004) |
| Status | Terminated |
| Reason | Design has insufficient articulating distance between the two component plates to prevent disassociation in vivo. |
| Root cause | Other |
| Action | The firm initiated the recall via telephone on 03/01/2004 to all distributors followed up by recall letter on 03/05/2004. |
| Quantity | 15 (1706-1024); 14 (1706-1026); 17 (1706-1028); 8 (1706-1030); 8 (1706-1032); and 25 (1757-1) |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K024326 | SPINAL CONCEPTS, INC. ANT-CER DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM Spinal Concepts, Inc., Jan 23, 2003 |