Device recall event
Recall event 97862: Orthofix U.S. LLC
FDA device recall · Class III · Open, Classified
Key facts
| Recall event number | 97862 |
|---|---|
| Recalling firm | Orthofix U.S. LLC |
| Recall class | Class III |
| Status | Open, Classified |
| 510(k) numbers | K172437, K200696, K203342, K203576 |
At a glance
- 1–9 Recalled products (Z-numbers)
- 1–9 Linked 510(k)s
- 1–9 Recall events for this firm
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recall events
A recall event groups every recalled product (Z-number) from one recall action by a firm. Class I recalls involve a reasonable probability of serious harm; Class III recalls are unlikely to cause harm.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database