Z-2273-2012Class II

TRESTLE LUXE Anterior Cervical Plating System, Product code KWQ. 510(k) K102820. The TRESTLE LUXE Anterior...

Name: Z-2273-2012 TRESTLE LUXE Anterior Cervical Plating System, Product code KWQ. 510(k) K102820. The TRESTLE LUXE Anterior...
Creator: Alphatec Spine, Inc.
Published: 2012-05-29
License: https://open.fda.gov/license/

Alphatec Spine, Inc. / initiated 2012-05-29 / Terminated / root cause: design

FDA source

Alphatec Spine, Inc. began a recall of TRESTLE LUXE Anterior Cervical Plating System, Product code KWQ. 510(k) K102820. The TRESTLE LUXE Anterior Cervical Plating System is a temporary device used... on 2012-05-29. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2273-2012
Classification: Class II
Status: Terminated
Initiated: 2012-05-29
Posted: 2012-08-27
Terminated: 2012-09-04
Recalling firm: Alphatec Spine, Inc.
Product: 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.
Product code: KWQ Appliance, Fixation, Spinal Intervertebral Body
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.
Root cause tag: design
FDA root cause: Device Design
Action: 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.)
Quantity in commerce: 38
Distribution: Nationwide Distribution.
Product codes and lots: Product code KWQ. 510(k) K102820 Part Number 71721. Lot numbers: 6629701, 6594701, 6434301, 6434302, 6434302R1.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2273-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2273-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-05	2012-08-27

Product code KWQ

K102820Class IIAppliance, Fixation, Spinal Intervertebral BodyAlphatec Spine, Inc. / cleared 2010-11-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)