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U.S. Department of Health and Human Services

Class 2 Device Recall 4.0mm Variable Angle, SelfDrilling Hexalobe Screw, 14mm

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  Class 2 Device Recall 4.0mm Variable Angle, SelfDrilling Hexalobe Screw, 14mm see related information
Date Initiated by Firm April 10, 2015
Date Posted April 29, 2015
Recall Status1 Terminated 3 on July 10, 2015
Recall Number Z-1547-2015
Recall Event ID 70958
510(K)Number K102820  
Product Classification Appliance, fixation, spinal intervertebral body - Product Code KWQ
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
Code Information Part Number: 71240-14 Lot: 685904
Recalling Firm/
Manufacturer		 Alphatec Spine, Inc.
5818 El Camino Real
Carlsbad CA 92008-8816
For Additional Information Contact
760-431-9286
Manufacturer 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.
FDA Determined
Cause 2		 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 (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.
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KWQ and Original Applicant = ALPHATEC SPINE, INC.
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