LINX Reflux Management System — Class II medical device recall Z-2037-2018
Terminated recall by Torax Medical, Inc., reported 2018-06-06, distributed nationwide. Possible out of specification condition which may allow a bead component to separate from an adjacent wire lin
| Recall number | Z-2037-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Torax Medical, Inc., Shoreview, MN, United States |
| Recall initiated | 2018-04-20 |
| Classified | 2018-05-31 |
| Reported by FDA | 2018-06-06 |
| Terminated | 2020-11-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, CH, DE, ES, FR, GB, IT |
| Quantity | 9,131 devices |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 00855106005011, 00855106005028, 00855106005035, 00855106005042, 00855106005059, 00855106005066 |
| Lot numbers | 6100 |
| Model numbers | 2170-10, 2170-11, 2170-6, 2170-7, 2170-8, 2170-9 |
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 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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2037-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.