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U.S. Department of Health and Human Services

Class 2 Device Recall Tibial Alignment Guide

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 Class 2 Device Recall Tibial Alignment Guidesee related information
Date Initiated by FirmJuly 13, 2018
Create DateOctober 11, 2018
Recall Status1 Terminated 3 on April 22, 2021
Recall NumberZ-2966-2018
Recall Event ID 80667
510(K)NumberK152217 
Product Classification Orthopedic manual surgical instrument - Product Code LXH
ProductTibial 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 2		Employee error
ActionThe firm notified their direct consignees by email on 07/13/2018 and requested the return of the product.
Quantity in Commerce7 units
DistributionCA, OH, NY, OK, FL, TX, SC, Germany, Spain, Switzerland, and UK
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = LXH
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