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.
FDA Recall Z-0201-2018 · Posted None
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Recalling FirmExactech, Inc.
Recall StatusTerminated
Product CodeHSN
Date Initiated2017-05-16
Date Terminated2021-04-22
Product Quantity9
Reason for Recall
Possible inner labeling and packaged device not matching the outer label on the box.
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.
Root Cause
Under Investigation by firm
Distribution Pattern
Distributed in North Carolina
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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