FDA Medical Device Recalls (openFDA)
Exactech, Inc.: Vantage 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.
- Recall number
- Z-0200-2018
- Recalling firm
- Exactech, Inc.
- Product
- Vantage 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.
- Status
- Terminated
- Initiated
- 2017-05-16
- Posted
- not on file
- Terminated
- 2021-04-22
- Reason
- Possible inner labeling and packaged device not matching the outer label on the box.
- Root cause
- 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
- 9
- Distribution
- Distributed in North Carolina
- Lot, serial or model codes
- Catalog Number 350-21-13, Serial Range 4536756 - 4536764, Expiration August 2024
- 510(k) numbers
- ["K152217"]
- PMA numbers
- not on file
- Product code
- HSN
- Firm FEI
- 1038671
- Firm city
- Gainesville
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28