Device recall
Z-1072-2022: Radial Head Replacement System Implant is a one-piece, stemmed radial head…
FDA device recall · Class II · Synthes (USA) Products LLC
Key facts
| Recall number (Z-number) | Z-1072-2022 |
|---|---|
| Recall event | 89972 |
| Product | Radial Head Replacement System Implant is a one-piece, stemmed radial head replacement. The radial head is available in diameters of 19, 22 and 25mm. The radial stems range from 5.5 to 8.5mm in diameter and from 21 24mm in length. |
| Product code | KWI |
| Recalling firm | Synthes (USA) Products LLC |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K183618 |
| FEI number | 3008812560 |
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