FDA recall Z-1208-2019

Exactech, Inc. · Class II · device

Product

Truliant Tibial Fit Tray Cemented SZ 3F / 3T, Catalog Number 02-022-45-3030 Product Usage: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented The OPTETRAK Comprehensive Knee Systems are indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems.

Reason for recall

2.5 Truliant Fit Trays were mismarked as 3

Distribution

US Nationwide Distribution in the states of AR, CA, OH, OK, IN, MN, NJ, TN, SC, FL

Key facts

Status
Terminated
Initiation date
2019-03-13
Report date
2019-05-01
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-1208-2019