Device recall
Z-1360-2016: Arthrex Deltoid Ligament Reconstruction Implant System. Intended as a fixation…
FDA device recall · Class II · Arthrex, Inc.
Key facts
| Recall number (Z-number) | Z-1360-2016 |
|---|---|
| Recall event | 73579 |
| Product | Arthrex Deltoid Ligament Reconstruction Implant System. Intended as a fixation post, a distribution bridge or for distributing suture tension over areas of ligament or tendon repair utilizing titanium buttons. |
| Product code | HRS |
| Recalling firm | Arthrex, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 24, 2019 |
| 510(k) numbers | K031666 |
| FEI number | 1220246 |
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