Device recall
Z-1197-2018: AIM Tibial Nails intramedullary fixation rod - NON-STERILE; Item numbers…
FDA device recall · Class II · Zimmer Biomet, Inc.
Key facts
| Recall number (Z-number) | Z-1197-2018 |
|---|---|
| Recall event | 79409 |
| Product | AIM Tibial Nails intramedullary fixation rod - NON-STERILE; Item numbers: 810508255 NAIL TIB DYN 08 X 25.5 810508270 NAIL TIB DYN 08 X 27.0 810508285 NAIL TIB DYN 08 X 28.5 810508300 NAIL TIB DYN 08 X 30.0 810508315 NAIL TIB DYN 08 X 31.5 810508330 NAIL TIB DYN 08 X 33.0 810508345 NAIL TIB DYN 08 X… |
| Product code | HSB |
| Recalling firm | Zimmer Biomet, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 2, 2019 |
| 510(k) numbers | K972183 |
| FEI number | 1825034 |
At a glance
- 1–9 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