Device recall
Z-2037-2018: LINX Reflux Management System, Implant Suture, 12-17 Bead, 0.7T, Product Code…
FDA device recall · Class II · Torax Medical, Inc.
Key facts
| Recall number (Z-number) | Z-2037-2018 |
|---|---|
| Recall event | 79822 |
| Product | LINX Reflux Management System, Implant Suture, 12-17 Bead, 0.7T, Product Code LS-xx, sterile, Rx only. Labeled as: a. Product Code LS-12; b. Product Code LS-13; c. Product Code LS-14; d. Product Code LS-15; e. Product Code LS-16; f. Product Code LS-17; Laparoscopic, fundic-sparing anti-reflux… |
| Product code | LEI |
| Recalling firm | Torax Medical, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 4, 2020 |
| PMA numbers | P100049 |
| FEI number | 3008766073 |
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