Trestle Anterior Cervical Plate 1-level assembly, Part Number: 61001-026. Alphatec Spine, Carlsbad, CA 92008. Intended f
FDA device recall Z-1746-2010 · posted 2010-06-02 · Terminated
Recall details
- Recalling firm
- Alphatec Spine, Inc.
- 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.
- 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.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- KWQ
- Quantity affected
- 13 units
- Distribution
- Nationwide Distribution -- AL, CA, FL, TN, TX and UT.
- Date initiated
- 2009-08-25
- Date posted
- 2010-06-02
- Date terminated
- 2010-06-07
- Location
- Carlsbad, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NEXT GENERATION ANTERIOR CERVICAL PLATING SYSTEM (K070681) | Alphatec Spine, Inc. | 2007-05-04 |