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U.S. Department of Health and Human Services

Class 2 Device Recall Tibial Insert

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  Class 2 Device Recall Tibial Insert see related information
Date Initiated by Firm August 10, 2020
Create Date August 31, 2020
Recall Status1 Open3, Classified
Recall Number Z-2926-2020
Recall Event ID 86261
510(K)Number K152217  
Product Classification Prosthesis, ankle, semi-constrained, cemented, metal/polymer - Product Code HSN
Product The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm.
Code Information Catalog Number: 350-22-44 Lot numbers: 05144883 and 05144884 Serial Numbers: 6417984, 6417989, 6417996, 6417997, 6417998, 6418002, 6418003, 6488668, 6488673,6488674,6488675.
Recalling Firm/
Manufacturer		 Exactech, Inc.
2320 NW 66th Ct
Gainesville FL 32653-1630
For Additional Information Contact Courtney Senter
352-377-1140
Manufacturer Reason
for Recall		 The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm, were found to have a labeling error. Exactech is recalling the Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm because they were found to have a labeling error. The upper right corner of the label incorrectly identifies the implant size as 3 when the implant size is 4.
FDA Determined
Cause 2		 Error in labeling
Action On August 18, 2020 Exactech sent an Urgent Product Recall Notice to all its consignees with the following instructions: -Immediately cease distribution or use of this product. -Extend this information to your accounts that may have this product in their possession. - Identify and quarantine any of the subject devices in your inventory (including loaner kits). -Complete and returned the attached Recall Inventory Response Form to Exactech via email at recalls@exac.com.
Quantity in Commerce 11 units
Distribution Domestic: CO,FL,OK, PA. International: Chile
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = HSN and Original Applicant = EXACTECH INC
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