FDA recall Z-0200-2018

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.

Reason for recall

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

Distribution

Distributed in North Carolina

Key facts

Status

Terminated

Initiation date

2017-05-16

Report date

2017-12-13

Termination date

2021-04-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Gainesville, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0200-2018