Device recall
Z-1364-2020: Truliant Splined Stem Extension, 18mm x 120mm - Product Usage: The devices are…
FDA device recall · Class II · Exactech, Inc.
Key facts
| Recall number (Z-number) | Z-1364-2020 |
|---|---|
| Recall event | 84961 |
| 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. |
| Product code | JWH |
| Recalling firm | Exactech, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K150890 |
| FEI number | 1038671 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database