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U.S. Department of Health and Human Services

Class 2 Device Recall Vintage Total Ankle Tibia Insert

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  Class 2 Device Recall Vintage Total Ankle Tibia Insert see related information
Date Initiated by Firm May 16, 2017
Create Date December 06, 2017
Recall Status1 Open3, Classified
Recall Number Z-0201-2018
Recall Event ID 77479
510(K)Number K152217  
Product Classification Prosthesis, ankle, semi-constrained, cemented, metal/polymer - Product Code HSN
Product Vantage Total Ankle Tibial Insert, Fixed Bearing, 10 mm, Left, Size 3. Exactech Inc.

Intended for patients with ankle joints damage by severe rheumatoid, post-traumatic, or degenerative arthritis. It is also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present. Indicated for cemented use only.

Code Information Catalog Number 350-21-43, Serial Range 4537323 - 4537331, Expiration August 2024
Recalling Firm/
Manufacturer
Exactech, Inc.
2320 NW 66th Ct
Gainesville FL 32653-1630
For Additional Information Contact
352-377-1140
Manufacturer Reason
for Recall
Possible inner labeling and packaged device not matching the outer label on the box.
FDA Determined
Cause 2
Under Investigation by firm
Action Customers were notified via letter dated May 16, 2017. Instructions included to immediately cease distribution of the affected products, identify and quarantine any devices in inventory, complete and return the Recall Inventory Response Form, notify customers if further distributed. For further questions, please call (352) 377-1140.
Quantity in Commerce 9
Distribution Distributed in North Carolina
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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