RegWardenFDA facility compliance records
Recall

Class II — Alphatec Spine, Inc.

Recalling firmALPHATEC HOLDINGS, INC.
Registered facilityView this company's 3 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusTerminated
ReasonOn 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.
ProductTRESTLE 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 (i…
Quantity38
DistributionNationwide Distribution.
Initiated2012-05-29
Classified2012-08-27
Terminated2012-09-04
Recall numberZ-2273-2012
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Alphatec Spine, Inc. (Z-2273-2012).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/51437/

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