Z-1547-2015Class II

4.0mm Variable Angle, Self-Drilling Hexalobe Screw, 14mm Alphatec Spine Solutions for the Aging Spine Trestle...

Name: Z-1547-2015 4.0mm Variable Angle, Self-Drilling Hexalobe Screw, 14mm Alphatec Spine Solutions for the Aging Spine Trestle...
Creator: Alphatec Spine, Inc.
Published: 2015-04-10
License: https://open.fda.gov/license/

Alphatec Spine, Inc. / initiated 2015-04-10 / Terminated / root cause: manufacturing process

FDA source

Alphatec Spine, Inc. began a recall of 4.0mm Variable Angle, Self-Drilling Hexalobe Screw, 14mm Alphatec Spine Solutions for the Aging Spine Trestle Luxe Anterior Cervical Plating System REF... on 2015-04-10. FDA classified it as Class II and gives the reason as "During a field audit it was discovered by an employee that a 16mm Trestle Luxe Screw has been both laser marked and labeled as a 14mm Trestle Luxe Screw (4.0mm Variable Angle, Self-Drilling Hexalobe Screw, 14mm). As a...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1547-2015
Classification: Class II
Status: Terminated
Initiated: 2015-04-10
Posted: 2015-04-29
Terminated: 2015-07-10
Recalling firm: Alphatec Spine, Inc.
Product: 4.0mm Variable Angle, Self-Drilling Hexalobe Screw, 14mm Alphatec Spine Solutions for the Aging Spine Trestle Luxe Anterior Cervical Plating System REF 71240-14 LOT XXXXXX Alphatec Spine, Inc. EN: 4.0MM Variable Angle, Self--Drilling Hexalobe Screw, 14MM (TI-6AL-4V ELI) NON STERILE Single Use Only
Product code: KWQ Appliance, Fixation, Spinal Intervertebral Body
Reason for recall: During a field audit it was discovered by an employee that a 16mm Trestle Luxe Screw has been both laser marked and labeled as a 14mm Trestle Luxe Screw (4.0mm Variable Angle, Self-Drilling Hexalobe Screw, 14mm). As a result the firm recalling the affected lots codes for this mislabeling.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Alphatec Spine sent an Urgent-Medical Device Recall Notification dated April 7, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The firm first requested that customers notify their consignees of the recall and the risk, and risk mitigation factors. The firm requests that customers take the following field actions: -Upon receipt of the Field Safety Notice to review inventory to determine if affected screw --part number 71240-14, lot 685904 is in their possession. -If the product is in their possession to please abstain from use and contact Alphatec Spine Customer Service ([email protected]) immediately for instructions on how to return the affected product. All shipping instructions will be provided, including replace product and/or credit. -Fill out page 3 of the letter to confirm that they have read the notification and have take all necessary actions stated in the notification. -Return a signed copy using one of the methods below: Mail to: Alphatec Spine, Inc. 5818 El Camino Real Carlsbad, CA 92008 Fax to: 1-800 431-7729 For further questions call ( 760) 431-9286.
Quantity in commerce: (244 units in US and 61 units OUS)
Distribution: Worldwide Distribution - US Distribution to the states of: KS, LA, TN, NJ, KY, CA, FL, OR, OK, AZ, WI, CO, IN, NH, AR, UT, and AL., and to the countries of : Spain, Japan, Belgium, and Saudi Arabia.
Product codes and lots: Part Number: 71240-14 Lot: 685904

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1547-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1547-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-06	2015-04-29

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)