FDA recall Z-2926-2020

Product

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

Reason for recall

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.

Distribution

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

Key facts

Status

Ongoing

Initiation date

2020-08-10

Report date

2020-09-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Gainesville, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2926-2020