Device recall
Z-0432-2026: Brand Name: Klassic BiPolar Head Model/Catalog Number: 3205.41.022 Klassic…
FDA device recall · Class II · Total Joint Orthopedics, Inc.
Key facts
| Recall number (Z-number) | Z-0432-2026 |
|---|---|
| Recall event | 97708 |
| Product | Brand Name: Klassic BiPolar Head Model/Catalog Number: 3205.41.022 Klassic BiPolar Head, 41 mm OD, 22 mm Head; 3205.42.022 Klassic BiPolar Head, 42 mm OD, 22 mm Head; 3205.43.022 Klassic BiPolar Head, 43 mm OD, 22 mm Head; 3205.44.028 Klassic BiPolar Head, 44 mm OD, 28 mm Head; 3205.45.028 Klassic… |
| Product code | KWY |
| Recalling firm | Total Joint Orthopedics, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K143113 |
| FEI number | 3008544874 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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