LINX Reflux Management System, Implant Clasp, 13-17 Bead, 1.5T, Product Code LXMC-xx, sterile, Rx only. Labeled as: a. Product Code LXMC-13; b. Product Code LXMC-14; c. Product Code LXMC-15; d. Product Code LXMC-16; e. Product Code LXMC-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.

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.

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 [email protected]; ( 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.