Recall Z-1208-2019 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Exactech, Inc.
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
| Date | Mar 13, 2019 |
| Status | Terminated |
| Reason | 2.5 Truliant Fit Trays were mismarked as 3 |
| Root cause | Under Investigation by firm |
| Action | The firm initiated the recall by telephone and email on 03/13/2019. The letter explained the issue and requested that the consignee cease use and distribution of the product, notify anyone to whom the recalled product was distributed, and quarantine the product. The firm is seeking return of the recalled units. |
| Quantity | 18 units |
| Distribution | US Nationwide Distribution in the states of AR, CA, OH, OK, IN, MN, NJ, TN, SC, FL |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152170 | Exactech Optetrak Logic Enhanced Assembly Exactech, Inc., Sep 3, 2015 |