Device recall
Z-0291-2018: Orthofix Power Drill Torque Limiter, Sterile, Rx Only, Single Use; Sold…
FDA device recall · Class II · Orthofix Srl
Key facts
| Recall number (Z-number) | Z-0291-2018 |
|---|---|
| Recall event | 77789 |
| Product | Orthofix Power Drill Torque Limiter, Sterile, Rx Only, Single Use; Sold individually and in the Galaxy UNYCO Diaphyseal Tibia Sterile Kit, Galaxy UNYCO Mini Kit Instruments Sterile, Galaxy UNYCO Diaphyseal Femur Box, Galaxy UNYCO Knee Bridging Box, Galaxy UNYCO Ankle Bridging Box - Unilateral Frame… |
| Product code | KTT |
| Recalling firm | Orthofix Srl |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 13, 2023 |
| 510(k) numbers | K142052, K153233 |
| FEI number | 3002807827 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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