Class II — Exactech, Inc.
| Recalling firm | EXACTECH, INC. |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 2.5 Truliant Fit Trays were mismarked as 3 |
| 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. |
| Quantity | 18 units |
| Distribution | US Nationwide Distribution in the states of AR, CA, OH, OK, IN, MN, NJ, TN, SC, FL |
| Initiated | 2019-03-13 |
| Classified | 2019-04-23 |
| Terminated | 2021-04-22 |
| Recall number | Z-1208-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Exactech, Inc. (Z-1208-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/82480/
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