LINX Reflux Management System, Implant Clasp, 12-17 Bead, 0.7T, Product Code LXC-xx, sterile, Rx only. Labeled as: a. Product Code LXC-12; b. Product Code LXC-13; c. Product Code LXC-14; d. Product Code LXC-15; e. Product Code LXC-16; f. Product Code LXC-17; Laparoscopic, fundic-sparing anti-reflux
Check against the official notice below — it lists the full affected range.
Torax Medical, Inc. is recalling 9,131 LINX Reflux Management System implant devices worldwide 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 a discontinuous or open device. The affected devices are 12-17 bead, 0.7T models with product codes LXC-12 through LXC-17 and specific lot numbers ranging from 6100 through 16557. The devices were distributed across all US states and several European countries including Austria, France, Germany, Italy, Scotland, Spain, Switzerland, and the United Kingdom.
The recall affects implants that were implanted in patients who received this device. The source document does not specify what remedy or action affected consumers should take in response to this recall.
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 LXC-12, Part No. 3718-12, GTIN 00855106005134; b. Product Code LXC-13, Part No. 3718-13, GTIN 00855106005141; c. Product Code LXC-14, Part No. 3718-14, GTIN 00855106005158; d. Product Code LXC-15, Part No. 3718-15, GTIN 00855106005165; e. Product Code LXC-16, Part No. 3718-16, GTIN 00855106005172; f. Product Code LXC-17, Part No. 3718-17, GTIN 00855106005189; 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.