Date Initiated by Firm | May 16, 2017 |
Create Date | December 06, 2017 |
Recall Status1 |
Terminated 3 on April 22, 2021 |
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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = HSN
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