Device recall
Z-1757-2018: AEQUALIS HUMERAL NAIL DRILL BIT, REF 7020140 Product Usage: The Aequalis Humeral…
FDA device recall · Class II · Tornier, Inc
Key facts
| Recall number (Z-number) | Z-1757-2018 |
|---|---|
| Recall event | 79907 |
| Product | AEQUALIS HUMERAL NAIL DRILL BIT, REF 7020140 Product Usage: The Aequalis Humeral Nail system is intended to provide temporary stabilization of various types of proximal and/or diaphyseal fractures of the humerus. Types of fractures include, but are not limited to, non-unions, malunions… |
| Product code | HTW |
| Recalling firm | Tornier, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 12, 2021 |
| 510(k) numbers | K082754 |
| FEI number | 3000718467 |
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