Recall Z-1364-2020 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Exactech, Inc.
Truliant Splined Stem Extension, 18mm x 120mm - Product Usage: The devices are used in a cemented total knee prosthesis system, which provides femoral components, tibial inserts, stems, augments, and surgical instrumentation for use in primary and revision total knee arthroplasty.
| Date | Jan 27, 2020 |
| Status | Open, Classified |
| Reason | These Truliant Splined Stem Extension, 18mm x 120mm were found to have a labeling error. The upper right corner of the label incorrectly identifies the implant size as 17mm x 80mm when the implant size is 18mm x 120mm. |
| Root cause | Labeling mix-ups |
| Action | Exactech distributed the recall notice to the consignees in possession of affected inventory by electronic mail on 7 January 2020. In order to comply with the notice, consignees have been instructed to: "Immediately cease distribution or use of this product. "Extend the information to their accounts that may have this product in their possession. "Identify and quarantine any of the subject devices in their inventory "Complete and return the attached Recall Acknowledgment Form and Recall Inventory Response Form to Exactech. |
| Quantity | 4 units |
| Distribution | US Nationwide distribution in the states of AZ, CO and FL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K150890 | Exactech Optetrak Logic CC Exactech, Inc., May 29, 2015 |