Device recall
Z-1057-2017: Chord-X Chordal Sizer is designed to assist in determining the proper length of…
FDA device recall · Class II · On-X Life Technologies, Inc.
Key facts
| Recall number (Z-number) | Z-1057-2017 |
|---|---|
| Recall event | 75951 |
| Product | Chord-X Chordal Sizer is designed to assist in determining the proper length of chordal replacement prostheses to repair the mitral valve and help the surgeon select a preconfigured prosthesis, or configure the correct size using straight suture material, during mitral valve repair. |
| Product code | PAW |
| Recalling firm | On-X Life Technologies, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 13, 2017 |
| 510(k) numbers | K141060 |
| FEI number | 3001584317 |
At a glance
- 1–9 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