Device recall
Z-1190-2017: Offset Reamer Handle, T5766 Product Usage: The reamer handles are re-usable…
FDA device recall · Class II · Greatbatch Medical
Key facts
| Recall number (Z-number) | Z-1190-2017 |
|---|---|
| Recall event | 76236 |
| Product | Offset Reamer Handle, T5766 Product Usage: The reamer handles are re-usable surgical instruments used in arthroplasty surgery of the hip joints, where either total joint replacement or resurfacing surgery is performed using a reamer cutting instrument. The reamer handles are intended for use with a… |
| Product code | LXH |
| Recalling firm | Greatbatch Medical |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 8, 2019 |
| FEI number | 2183787 |
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