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U.S. Department of Health and Human Services

Class 2 Device Recall Vantage Total Ankle Tibia Insert

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 Class 2 Device Recall Vantage Total Ankle Tibia Insertsee related information
Date Initiated by FirmMay 16, 2017
Create DateDecember 06, 2017
Recall Status1 Terminated 3 on April 22, 2021
Recall NumberZ-0200-2018
Recall Event ID 77479
510(K)NumberK152217 
Product Classification Prosthesis, ankle, semi-constrained, cemented, metal/polymer - Product Code HSN
ProductVantage Total Ankle Tibial Insert, Fixed Bearing, 7 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 350-21-13, Serial Range 4536756 - 4536764, 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
ActionCustomers 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 Commerce9
DistributionDistributed in North Carolina
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 = HSN
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