Recall Z-1746-2010 ยท KWQ Appliance, Fixation, Spinal Intervertebral Body
Alphatec Spine, Inc.
Trestle Anterior Cervical Plate 1-level assembly, Part Number: 61001-026. Alphatec Spine, Carlsbad, CA 92008. Intended for the temporary stabilization of the anterior spine during the development of fusion in patients.
| Date | Jun 2, 2010 (initiated Aug 25, 2009) |
| Status | Terminated |
| Reason | The recall was initiated after the firm discovered that the affected lot was labeled incorrectly in that the packaging label indicates that the part number of the lot is 61002-026, which corresponds to a two-level Trestle Anterior Cervical Plate implant. |
| Root cause | Labeling mix-ups |
| Action | Alphatec Spine initiated a recall communication via telephone beginning August 25, 2009. Customers were given an explanation of the problem and instructed to check their inventory for the affected product. The firm indicated that they would arrange to have Federal Express contact customers for pick-up of the affected product(s) and replacement product would be sent out immediately. For further information, contact Alphatec Spine at 1-800-922-1356. |
| Quantity | 13 units |
| Distribution | Nationwide Distribution -- AL, CA, FL, TN, TX and UT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070681 | NEXT GENERATION ANTERIOR CERVICAL PLATING SYSTEM Alphatec Spine, Inc., May 4, 2007 |