Class 2 Device Recall Exactech Spine, Large Set Screw

• Date Initiated by Firm: March 06, 2009
• Date Posted: July 10, 2015
• Recall Status: Terminated on July 14, 2015
• Recall Number: Z-2059-2015
• Recall Event ID: 71528
• 510(K)Number: K051216
• Product Classification: Orthosis, spondylolisthesis spinal fixation - Product Code MNH
• Product: Altiva / Exactech Spine, Large Set Screw, Catalog Number 28202, Lot Number AS05107. Intended to provide immobilization and stabilization of spinal segments.
• Code Information: Catalog Number 28202, Lot Number AS05107
• Recalling Firm/ Manufacturer: Exactech, Inc.; 2320 NW 66th Ct; Gainesville FL 32653-1630
• For Additional Information Contact: Graham L Cuthbert; 352-377-1140
• Manufacturer Reason for Recall: Incorrect thread form on the screw.
• FDA Determined Cause: Device Design
• Action: Consignees were notified with a Product Recall Notice on 03/06/2009 that all screws must be checked to ensure that any discrepant products to be removed from the field.
• Quantity in Commerce: 749 devices
• Distribution: Distributed in the states of FL, GA, IL, NY, TX, and WA.
• 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 = MNH