FDA Device recall Z-1364-2020
Truliant Splined Stem Extension, 18mm x 120mm - Product Usage: The devices are used in a cemented total knee prosthesis system, which provi…
- FDA Device
- Class II
- ongoing
- Published 2020-03-04
On 2020-03-04 the FDA classified a Class II recall of Truliant Splined Stem Extension, 18mm x 120mm - Product Usage: The devices are used in a cemented total knee prosthesis system, which provi… by Exactech, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1364-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-01-27 |
| Published | 2020-03-04 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Exactech |
| Distribution | US |
Product
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.
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.
Identifiers
| code_info | Catalog no: 02-012-64-1812 Serial number: 6366405, 6367075, 6367076 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1364-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.