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

FDA device recall Z-1547-2015 · posted 2015-04-29 · Terminated

Recall details

Recalling firm

Alphatec Spine, Inc.

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.

Action taken

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 (customerservice@alphatecspine.com) 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.

Root cause

Employee error

Status

Terminated

Product code

KWQ

Quantity affected

(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.

Date initiated

2015-04-10

Date posted

2015-04-29

Date terminated

2015-07-10

Location

Carlsbad, CA

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