LINX Reflux Management System, Implant Suture, 12-17 Bead, 0.7T, Product Code LS-xx, sterile, Rx only. Labeled as: a. Product Code LS-12; b. Product Code LS-13; c. Product Code LS-14; d. Product Code LS-15; e. Product Code LS-16; f. Product Code LS-17; Laparoscopic, fundic-sparing anti-reflux proced
Check against the official notice below — it lists the full affected range.
Torax Medical is recalling 9,131 LINX Reflux Management System implants worldwide due to a possible manufacturing defect that could allow a bead component to separate from an adjacent wire link. This separation could result in the device becoming discontinuous or open, potentially affecting its ability to function properly. The affected devices were distributed across nearly all U.S. states and several European countries.
The recalled implants include product codes LS-12 through LS-17 with various lot numbers ranging from 6100 through 16557. The source document does not specify what actions affected consumers should take regarding 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 LS-12, Part No. 2170-6, GTIN 00855106005011; b. Product Code LS-13, Part No. 2170-7, GTIN 00855106005028; c. Product Code LS-14, Part No. 2170-8, GTIN 00855106005035; d. Product Code LS-15, Part No. 2170-9, GTIN 00855106005042; e. Product Code LS-16, Part No. 2170-10, GTIN 00855106005059; f. Product Code LS-17, Part No. 2170-11, GTIN 00855106005066; 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.