Torax Medical, Inc.: Medical Device Recall in 2018 - (Recall #: Z-2041-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: April 20, 2018

Date Posted: June 6, 2018

Recall Number: Z-2041-2018

Event ID: 79822

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.

Status: Terminated

Product Quantity: 9,131 devices in total

Code Information:

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

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated