Optetrak Logic CC Stem Extension — Class II medical device recall Z-3209-2018
Ongoing recall by Exactech, Inc., reported 2018-09-26, distributed in OH. Potentially have non-conforming internal threads.
| Recall number | Z-3209-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Exactech, Inc., Gainesville, FL, United States |
| Recall initiated | 2018-05-08 |
| Classified | 2018-09-20 |
| Reported by FDA | 2018-09-26 |
| Distributed | OH |
| Quantity | 1 |
| Serial numbers | 5370045 |
| Model numbers | 02-012-60-2216 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3209-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.