Recall Z-0292-06 ยท KWQ Appliance, Fixation, Spinal Intervertebral Body
Abbott Spine
SC-AcuFix Core Instruments Surgical Techniques covering SC-AcuFix SlimLine, SlimLine Hybrid, Corpectomy, ThinLine and Ant-Cer Anterior Cervical Plating Systems.
| Date | Dec 17, 2005 (initiated Nov 14, 2005) |
| Status | Terminated |
| Reason | Modification to labeling for surgical implant. |
| Root cause | Other |
| Action | Firm contact of Sales Agencies by phone began on 11/11/05 to inform of changes to Surgical Techniques. Letter to surgeons using SC-AcuFix Systems as of 06/01/05 sent 11/14/05. |
| Quantity | Approximately 941 SC-AcuFix Core Instruments Surgical Techniques |
| Distribution | Nationwide. Surgical Techniques for the SC-AcuFix Anterior Cervical Plating Systems distributed to Sales Agencies and surgeons throughout the U.S. |
| 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 |
| K024326 | SPINAL CONCEPTS, INC. ANT-CER DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM Spinal Concepts, Inc., Jan 23, 2003 |
| K990005 | SPINAL CONCEPTS, INC. (SCI) ANTERIOR CERVICAL PLATE SYSTEM Spinal Concepts, Inc., Feb 12, 1999 |