—#183239

Product

The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm.

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: 350-22-44 Lot numbers: 05144883 and 05144884 Serial Numbers: 6417984, 6417989, 6417996, 6417997, 6417998, 6418002, 6418003, 6488668, 6488673,6488674,6488675.

Why it was recalled

The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm, were found to have a labeling error. Exactech is recalling the Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm because they were found to have a labeling error. The upper right corner of the label incorrectly identifies the implant size as 3 when the implant size is 4.

Root cause (FDA determination)

Error in labeling

Action the firm took

On August 18, 2020 Exactech sent an Urgent Product Recall Notice to all its consignees with the following instructions: -Immediately cease distribution or use of this product. -Extend this information to your accounts that may have this product in their possession. - Identify and quarantine any of the subject devices in your inventory (including loaner kits). -Complete and returned the attached Recall Inventory Response Form to Exactech via email at recalls@exac.com.

Recalling firm

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

Distribution

Distribution pattern: Domestic: CO,FL,OK, PA. International: Chile

Timeline

Recall initiated: 2020-08-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #183239. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.