FDA recall Z-3209-2018

Product

Optetrak Logic CC Stem Extension, 22mm x 160mm The OPTETRAK Logic CC Total Knee System is 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

Potentially have non-conforming internal threads.

Distribution

US Distribution to Ohio only.

Key facts

Status

Ongoing

Initiation date

2018-05-08

Report date

2018-09-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Gainesville, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3209-2018