FDA Device recall Z-3209-2018
Optetrak Logic CC Stem Extension, 22mm x 160mm The OPTETRAK Logic CC Total Knee System is indicated for use in skeletally mature individual…
- FDA Device
- Class II
- ongoing
- Published 2018-09-26
On 2018-09-26 the FDA classified a Class II recall of Optetrak Logic CC Stem Extension, 22mm x 160mm The OPTETRAK Logic CC Total Knee System is indicated for use in skeletally mature individual… by Exactech, citing potentially have non-conforming internal threads.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3209-2018 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2018-05-08 |
| Published | 2018-09-26 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Exactech |
| Distribution | OH |
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
Potentially have non-conforming internal threads.
Identifiers
| code_info | Catalog #: 02-012-60-2216 Serial Number: 5370045 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3209-2018%22
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