Recall Z-0880-05 ยท KWQ Appliance, Fixation, Spinal Intervertebral Body
Spinal Concepts, Inc
SC-AcuFix Thinline Low-Profile Anterior Cervical Plate System manufactured by Spinal Concepts, Inc., An Abbott Laboratories Company, Austin, Texas
| Date | Jun 11, 2005 (initiated Jul 1, 2002) |
| Status | Terminated |
| Reason | Complaints were recieved where swivels came out of plate and where the screw went through the plate. |
| Root cause | Other |
| Action | The firm initiated the recall via telephone communication from sales representatives around August 2002. |
| Quantity | 10 systems |
| Distribution | Systems were distributed to hospitals in CA, IL, IN, NC, MS, PA, NY and VA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K013979 | SC-ACUFIX THINLINE ANTERIOR CERVICAL PLATE SYSTEM Spinal Concepts, Inc., Feb 13, 2002 |