Device recall
Z-0810-2018: AccuLIF TL Insertion Handle The AccuLIF Insertion Handle attaches to the implant…
FDA device recall · Class II · Howmedica Osteonics Corp.
Key facts
| Recall number (Z-number) | Z-0810-2018 |
|---|---|
| Recall event | 79147 |
| Product | AccuLIF TL Insertion Handle The AccuLIF Insertion Handle attaches to the implant and is specifically designed to allow a surgeon to insert the implant into the disc space with a fixed engagement between the two components to permit a controlled positioning of the implant in the anterior portion of… |
| Product code | LXH |
| Recalling firm | Howmedica Osteonics Corp. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 31, 2018 |
| FEI number | 3004024955 |
At a glance
- None 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