Truliant Tibial Fit Tray Cemented SZ 3F / 3T — Class II medical device recall Z-1208-2019
Terminated recall by Exactech, Inc., reported 2019-05-01, distributed nationwide. 2.5 Truliant Fit Trays were mismarked as 3
| Recall number | Z-1208-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Exactech, Inc., Gainesville, FL, United States |
| Recall initiated | 2019-03-13 |
| Classified | 2019-04-23 |
| Reported by FDA | 2019-05-01 |
| Terminated | 2021-04-22 |
| Distributed | Nationwide (US) |
| Quantity | 18 units |
| Serial numbers | 5774515, 5774517, 5774518, 5774519, 5774520, 5774521, 5774525, 5774526, 5774527, 5774529, 5774531, 5774532, 5774533, 5774534, 5774535, 5774541, 5774543 |
| Model numbers | 02-022-45-3030 |
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
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-1208-2019. 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.