FDA Device recall Z-2041-2018
LINX Reflux Management System, Implant Clasp, 13-16 Bead, 1.5T, Product Code LXM-xx, sterile, Rx only
- FDA Device
- Class II
- terminated
- Published 2018-06-06
On 2018-06-06 the FDA classified a Class II recall of LINX Reflux Management System, Implant Clasp, 13-16 Bead, 1.5T, Product Code LXM-xx, sterile, Rx only by Torax Medical, citing possible out of specification condition which may allow a bead component to separate from an adjacent wire link. This condition may result in a discontinuous or open LINX device.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2041-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-04-20 |
| Published | 2018-06-06 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Torax Medical |
| Distribution | US |
Product
LINX Reflux Management System, Implant Clasp, 13-16 Bead, 1.5T, Product Code LXM-xx, sterile, Rx only. Labeled as: a. Product Code LXM-13; b. Product Code LXM-14; c. Product Code LXM-15; d. Product Code LXM-16; Laparoscopic, fundic-sparing anti-reflux procedure indicated for patients diagnosed with Gastroesophageal Reflux Disease (GERD) as defined by abnormal pH testing, and who are seeking an alternative to continuous acid suppression therapy (i.e. proton pump inhibitors or equivalent) in the management of their GERD.
Reason
Possible out of specification condition which may allow a bead component to separate from an adjacent wire link. This condition may result in a discontinuous or open LINX device.
Identifiers
| code_info | a. Product Code LXM-13, Part No. 4549-13, GTIN 00855106005394; b. Product Code LXM-14, Part No. 4549-14, GTIN 0085510…a. Product Code LXM-13, Part No. 4549-13, GTIN 00855106005394; b. Product Code LXM-14, Part No. 4549-14, GTIN 00855106005400; c. Product Code LXM-15, Part No. 4549-15, GTIN 00855106005417; d. Product Code LXM-16, Part No. 4549-16, GTIN 00855106005424; Lot No. 6100 through 14055, 15286, 15287, 15314, 15315, 15317, and 16557 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2041-2018%22
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