Device 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.
Z-1208-2019
Product summary
- Firm
- Exactech, Inc.
- Event
- Event 82480
- Status
- Terminated
- Classification
- Class II
- Quantity
- 18 units
- Official record key
device-enforcement:Z-1208-2019
Official wording
Reason: 2.5 Truliant Fit Trays were mismarked as 3
Code information: Serial Numbers: 5774515, 5774517, 5774518, 5774519, 5774520, 5774521, 5774525, 5774526, 5774527, 5774529, 5774531, 5774532, 5774533, 5774534, 5774535, 5774541, 5774543
Distribution pattern: US Nationwide Distribution in the states of AR, CA, OH, OK, IN, MN, NJ, TN, SC, FL
Derived failure modes
-
Unknown
2.5 Truliant Fit Trays were mismarked as 3