Device recall
Z-0775-2020: Medacta Shoulder SYSTEM HUMERAL ANATOMICAL METAPHYSIS, REF 04.01.0023 through…
FDA device recall · Class II · Medacta Usa Inc
Key facts
| Recall number (Z-number) | Z-0775-2020 |
|---|---|
| Recall event | 84397 |
| Product | Medacta Shoulder SYSTEM HUMERAL ANATOMICAL METAPHYSIS, REF 04.01.0023 through 04.01.0055, all sizes - Product Usage: The Medacta Anatomic Shoulder Prosthesis is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with an intact or reparable… |
| Product code | KWS |
| Recalling firm | Medacta Usa Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 21, 2021 |
| 510(k) numbers | K170910 |
| FEI number | 3006639916 |
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