Torax Medical, Inc.: 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.

Recall number

Z-2040-2018

Recalling firm

Torax Medical, Inc.

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.

Status

Terminated

Initiated

2018-04-20

Posted

not on file

Terminated

2020-11-04

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.

Root cause

Nonconforming Material/Component

Action

The firm, Consignees Torax Medical Inc., sent an "URGENT: FIELD SAFETY NOTICE (REMOVAL)" letter mailed on approximately 04/20/2018 (US consignees and physicians) and 04/23/2018 (OUS consignees and physicians). The letter described the product, problem and actions to be taken. The customers were instructed to examine inventory for affected product, quarantine any affected product, communicate the issue to all relevant operating room or materials management personnel, forward the recall information to facilities where the product may have been forwarded to, complete the Business Reply Form confirming receipt of this notice and return it to Torax Medical, Inc. within three (3) business days via email at brf@toraxmedical.com; ( return the BRF even if you do not have the product lot subject to this recall.), and arrange the return of any affected product on hand. Additionally, a recall notification will be sent to sent to physicians outlining the reason for recall and to advise them to monitor their patients. Question regarding the recall can be directed to the Customer Support Cetner at 1-877-384-4266, which is open Monday through Friday, 7:30 AM to 6:30 PM ET.

Quantity

9,131 devices in total

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.

Lot, serial or model codes

a. Product Code LX-12, Part No. 2684-12, GTIN 00855106005073;  b. Product Code LX-13, Part No. 2684-13, GTIN 00855106005080;  c. Product Code LX-14, Part No. 2684-14, GTIN 00855106005097;  d. Product Code LX-15, Part No. 2684-15, GTIN 00855106005103;  e. Product Code LX-16, Part No. 2684-16, GTIN 00855106005110;  f. Product Code LX-17, Part No. 2684-17, GTIN 00855106005127;   Lot No. 6100 through 14055, 15286, 15287, 15314, 15315, 15317, and 16557

510(k) numbers

not on file

PMA numbers

["P100049"]

Product code

LEI

Firm FEI

3008766073

Firm city

Shoreview

Firm state

MN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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