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TRESTLE LUXE Anterior Cervical Plating System, Product code… recallZ-2273-2012 · Alphatec Spine, Inc. · initiated May 29, 2012

Class II Terminated All recalls posted in August 2012

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Alphatec Spine, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Device Design

What the company is doing

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 [email protected] questions regarding this recall.)

Recall details

Recall number
Z-2273-2012
Recall class
Class II
Status
Terminated
Initiated by the company
May 29, 2012
Posted by the FDA
Aug 27, 2012
Recalling firm
Alphatec Spine, Inc.
Quantity
38
Product code
KWQ
FDA submissions
K102820
Distribution
Nationwide Distribution.

Product description

TRESTLE LUXE Anterior Cervical Plating System, Product code KWQ. 510(k) K102820. The TRESTLE LUXE Anterior Cervical Plating System is a temporary device used to stabilize the cervical spine during bone fusion development. Device implants include a range of plate sizes and bone screws to provide the versatility required for the specific indications noted. Fixation is achieved by means of a rigid plate that is surgically attached to the spine with bone screws. The TRESTLE LUXE Anterior Cervical Plating System is intended for use in the anterior cervical spine (C2-C7). Patients with trauma (including fractures), spondylolisthesis, and pseudoarthrosis, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, tumors, and failed previous fusion.

Code information (models, lots, serial numbers)

Product code KWQ. 510(k) K102820 Part Number 71721. Lot numbers: 6629701, 6594701, 6434301, 6434302, 6434302R1.

Other devices under the same FDA submission

23 devices cleared under K102820 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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