Class 2 Device Recall Tibial Alignment Guide

• Date Initiated by Firm: July 13, 2018
• Create Date: October 11, 2018
• Recall Status: Terminated on April 22, 2021
• Recall Number: Z-2966-2018
• Recall Event ID: 80667
• 510(K)Number: K152217
• Product Classification: Orthopedic manual surgical instrument - Product Code LXH
• Product: Tibial Alignment Guide, REF 351-10-00 Vantage Fixed Ankle system components for ankle replacements.
• Code Information: GTIN10885862525629, Lot Number 098299003
• Recalling Firm/ Manufacturer: Exactech, Inc.; 2320 NW 66th Ct; Gainesville FL 32653-1630
• For Additional Information Contact: 352-377-1140
• Manufacturer Reason for Recall: Exactech is recalling the Tibial Alignment Guide because the Global Trade Item Number (GTIN) on the device is incorrect. The GTIN on the device reads 10885862525629, when it should read 10885862525628.
• FDA Determined Cause: Employee error
• Action: The firm notified their direct consignees by email on 07/13/2018 and requested the return of the product.
• Quantity in Commerce: 7 units
• Distribution: CA, OH, NY, OK, FL, TX, SC, Germany, Spain, Switzerland, and UK
• 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 = LXH and Original Applicant = EXACTECH INC