Device recall
Z-1794-2021: WishBone Medical Plate and Screw System - Screw, Fixation, Bone, Washer, Bolt…
FDA device recall · Class II · Wishbone Medical, Inc.
Key facts
| Recall number (Z-number) | Z-1794-2021 |
|---|---|
| Recall event | 87940 |
| Product | WishBone Medical Plate and Screw System - Screw, Fixation, Bone, Washer, Bolt Nut. Part Number: PK-SMC0635NL-TI-US, PK-SMC0635NR-TI-US, PK-SMC0835NSL-TI-US, PK-SMC0835NSR-TI-US |
| Product code | HRS |
| Recalling firm | Wishbone Medical, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 28, 2022 |
| 510(k) numbers | K180736 |
| FEI number | 3013680140 |
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