# FDA recall Z-2040-2018

> **Torax Medical, Inc.** · Class II · device recall initiated 2018-04-20.

## Product

LINX Reflux Management System, Implant Clasp, 12-17 Bead, 0.7T, Product Code LX-xx, sterile, Rx only.  Labeled as:    a. Product Code LX-12;    b. Product Code LX-13;   c. Product Code LX-14;    d. Product Code LX-15;    e. Product Code LX-16;    f. Product Code LX-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.

## Distribution

Worldwide Distribution: US (nationwide) in states of: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY; and in countries of: Austria, France, Germany, Italy, Scotland, Spain, Switzerland, United Kingdom.

## Key facts

- **Recall number:** Z-2040-2018
- **Recalling firm:** Torax Medical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-04-20
- **Report date:** 2018-06-06
- **Termination date:** 2020-11-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Shoreview, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2040-2018

## Citation

> AI Analytics. FDA recall Z-2040-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2040-2018. Source: US FDA. Licensed CC0.

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