Device recall
Z-0392-2020: ORTHOFIX Catalogue Number: ref: 99-92503, PREFIX II DIAPHYSEAL COMPLETE KIT…
FDA device recall · Class II · Orthofix Srl
Key facts
| Recall number (Z-number) | Z-0392-2020 |
|---|---|
| Recall event | 84004 |
| Product | ORTHOFIX Catalogue Number: ref: 99-92503, PREFIX II DIAPHYSEAL COMPLETE KIT STERILE LONG SCREWS, RX ONLY, UDI: (01) 18033509855962 |
| Product code | JDW |
| Recalling firm | Orthofix Srl |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 1, 2022 |
| 510(k) numbers | K955848 |
| FEI number | 3002807827 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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