Device 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.
Z-3209-2018
Product summary
- Firm
- Exactech, Inc.
- Event
- Event 80763
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1
- Official record key
device-enforcement:Z-3209-2018
Official wording
Reason: Potentially have non-conforming internal threads.
Code information: Catalog #: 02-012-60-2216 Serial Number: 5370045
Distribution pattern: US Distribution to Ohio only.
Derived failure modes
-
Unknown
Potentially have non-conforming internal threads.