Device recall
Z-0372-2023: NextAR Shoulder Surgical Technique, Shoulder NextAR RSA Platform, CT based…
FDA device recall · Class II · Medacta Usa Inc
Key facts
| Recall number (Z-number) | Z-0372-2023 |
|---|---|
| Recall event | 91091 |
| Product | NextAR Shoulder Surgical Technique, Shoulder NextAR RSA Platform, CT based computer-assisted surgical navigation platform used to perform a reverse shoulder arthroplasty on the glenoid |
| Product code | OLO |
| Recalling firm | Medacta Usa Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 23, 2023 |
| 510(k) numbers | K210153 |
| 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