Device recall
Z-2063-2018: TL-HEX TruLok Hexapod System, Double Row Footplates, TL-HEX Sterile, All Sizes…
FDA device recall · Class II · Orthofix Srl
Key facts
| Recall number (Z-number) | Z-2063-2018 |
|---|---|
| Recall event | 80114 |
| Product | TL-HEX TruLok Hexapod System, Double Row Footplates, TL-HEX Sterile, All Sizes: 120 MM, 140 MM, 160 MM, 180 MM, 200 MM. The TL-HEX TrueLock Hexapod System (TL-HEX) consists of rings, foot plates and struts to be used in conjunction with the TruLok external fixation system. The system is a metal bone… |
| Product code | KTT |
| Recalling firm | Orthofix Srl |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 13, 2021 |
| 510(k) numbers | K170650 |
| 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