medical Class II Updated 2018-06-06

Torax Medical, Inc. recalls LINX Reflux Management System, Implant Clasp, 13-16 Bead, 1.

Recalled Product

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.

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)

Lot/Code Info: 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

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