medical Class II Updated 2018-06-06

Torax Medical, Inc. recalls LINX Reflux Management System, Implant Clasp, 13-17 Bead, 1.

Recalled Product

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.

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 LXMC-13, Part No. 4550-13, GTIN 00855106005332; b. Product Code LXMC-14, Part No. 4550-14, GTIN 00855106005349; c. Product Code LXMC-15, Part No. 4550-15, GTIN 00855106005356; d. Product Code LXMC-16, Part No. 4550-16, GTIN 00855106005363; e. Product Code LXMC-17, Part No. 4550-17, GTIN 00855106005370; Lot No. 6100 through 14055, 15286, 15287, 15314, 15315, 15317, and 16557

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