TRESTLE LUXE Anterior Cervical Plating System, Product code KWQ. 510(k) K102820. The TRESTLE LUXE Anterior Cervical Plat
FDA device recall Z-2273-2012 · posted 2012-08-27 · Terminated
Recall details
- Recalling firm
- Alphatec Spine, Inc.
- Reason for recall
- On May 9th 2012 Alphatec Spine received a complaint which reported that the distal tip of the Trestle Luxe Slide Alignment Tool (Part Number 71721), does not properly fit into the hexalobe screw on the Trestle Luxe Plate.
- Action taken
- Alphatec Spine sent an "URGENT-MEDICAL DEVICE RECALL NOTIFICATION" letter dated May 29, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. A form was attached for customers to complete and return via fax to 760-431-0289. Contact Alphatec Spine's Customer Service Department at customerservice@alphatecspine.comfor questions regarding this recall.)
- Root cause
- Device Design
- Status
- Terminated
- Product code
- KWQ
- Quantity affected
- 38
- Distribution
- Nationwide Distribution.
- Date initiated
- 2012-05-29
- Date posted
- 2012-08-27
- Date terminated
- 2012-09-04
- Location
- Carlsbad, CA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY (K102820) | Alphatec Spine, Inc. | 2010-11-05 |