Device recall
Z-0695-2018: 1113 Gravity Tube Set Pk/24 -SH Product Usage: The FMS Gravity Tube Set is…
FDA device recall · Class II · DePuy Mitek, Inc., a Johnson & Johnson Co.
Key facts
| Recall number (Z-number) | Z-0695-2018 |
|---|---|
| Recall event | 79117 |
| Product | 1113 Gravity Tube Set Pk/24 -SH Product Usage: The FMS Gravity Tube Set is intended to deliver irrigation fluid from irrigation containers to the operative site during arthroscopic procedures. |
| Product code | JCY |
| Recalling firm | DePuy Mitek, Inc., a Johnson & Johnson Co. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 9, 2019 |
| FEI number | 1221934 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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