Z-1208-2019 Class II Terminated
FDA device recall Z-1208-2019 was initiated by Exactech, Inc. on March 13, 2019 and is designated Class II. Reason for recall: 2.5 Truliant Fit Trays were mismarked as 3 The recall status is terminated (terminated April 22, 2021). Affected quantity: 18 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 1, 2019
- Initiation Date
- March 13, 2019
- Termination Date
- April 22, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18 units
Product Description
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
Distribution Pattern
US Nationwide Distribution in the states of AR, CA, OH, OK, IN, MN, NJ, TN, SC, FL
Code Information
Serial Numbers: 5774515, 5774517, 5774518, 5774519, 5774520, 5774521, 5774525, 5774526, 5774527, 5774529, 5774531, 5774532, 5774533, 5774534, 5774535, 5774541, 5774543