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.
This recall has been terminated (originally issued June 2, 2010).
- Company
- Alphatec Spine, Inc.
- Recall Initiated
- August 25, 2009
- Posted
- June 2, 2010
- Terminated
- June 7, 2010
- Recall Number
- Z-1746-2010
- Quantity
- 13 units
- Firm Location
- Carlsbad, CA
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Nationwide Distribution -- AL, CA, FL, TN, TX and UT.
Lot / Code Info
Lot Number: 5481103
Root Cause
Labeling mix-ups
Action Taken
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.