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 procedu
Check against the official notice below — it lists the full affected range.
Torax Medical, Inc. is recalling 9,131 LINX Reflux Management System implants (product codes LX-12 through LX-17) due to a possible manufacturing defect that may allow a bead component to separate from an adjacent wire link. If this separation occurs, the device could become discontinuous or open, potentially affecting its ability to function as intended. 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 recall affects specific lot numbers ranging from 6100 through 14055, plus lots 15286, 15287, 15314, 15315, 15317, and 16557. 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 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.