Device recall
Z-3097-2024: ROTATION MEDICAL TENDON STAPLES (8) (narrow indication)-Intended for fixation of…
FDA device recall · Class II · Smith & Nephew Inc.
Key facts
| Recall number (Z-number) | Z-3097-2024 |
|---|---|
| Recall event | 95178 |
| Product | ROTATION MEDICAL TENDON STAPLES (8) (narrow indication)-Intended for fixation of prosthetic material to soft tissues. Product Number: 72205201 |
| Product code | GDW |
| Recalling firm | Smith & Nephew Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K131637 |
| FEI number | 3003604053 |
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