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 indicate
Check against the official notice below — it lists the full affected range.
Torax Medical, Inc. is recalling the LINX Reflux Management System Implant Clasp (13-17 Bead, 1.5T) due to a possible out-of-specification condition that may allow a bead component to separate from an adjacent wire link. This separation could result in the device becoming discontinuous or open. A total of 9,131 devices are affected across product codes LXMC-13 through LXMC-17, with lot numbers ranging from 6100 through 14055, plus specific lot numbers 15286, 15287, 15314, 15315, 15317, and 16557.
The affected devices were distributed worldwide, including throughout the United States and in Austria, France, Germany, Italy, Scotland, Spain, Switzerland, and the United Kingdom. The source document does not specify a remedy or instructions for what affected consumers should do.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. 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. Quantity: 9,131 devices in total 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.