Device recall
Z-0451-2019: Affixus Hip Fracture Nail 125 Deg 10x165mm, Item Number 816710165 The Affixus…
FDA device recall · Class II · Zimmer Biomet, Inc.
Key facts
| Recall number (Z-number) | Z-0451-2019 |
|---|---|
| Recall event | 81223 |
| Product | Affixus Hip Fracture Nail 125 Deg 10x165mm, Item Number 816710165 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures of the proximal femur. |
| Product code | HSB |
| Recalling firm | Zimmer Biomet, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 2, 2020 |
| 510(k) numbers | K100238 |
| 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