—#156246

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.

FDA product code: HSN — Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K152217
Affected lot / code info: Catalog Number 350-21-13, Serial Range 4536756 - 4536764, Expiration August 2024

Why it was recalled

Possible inner labeling and packaged device not matching the outer label on the box.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Exactech, Inc.
Address: 2320 NW 66th Ct, Gainesville, Florida 32653-1630

Distribution

Distribution pattern: Distributed in North Carolina

Timeline

Recall initiated: 2017-05-16
Terminated: 2021-04-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #156246. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.