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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Torax Medical, Inc.: 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.

Agency Publication Date: May 31, 2018
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Affected Products

Product: 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 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 suppre

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

Lot Numbers:
LS-12
LS-13
LS-14
LS-15
LS-16
LS-17
Product: 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 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

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

Lot Numbers:
LXC-12
LXC-13
LXC-14
LXC-15
LXC-16
LXC-17
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

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

Lot Numbers:
LXMC-13
LXMC-14
LXMC-15
LXMC-16
LXMC-17
Product: 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 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 suppres

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

Lot Numbers:
LX-12
LX-13
LX-14
LX-15
LX-16
LX-17
Product: LINX Reflux Management System, Implant Clasp, 13-16 Bead, 1.5T, Product Code LXM-xx, sterile, Rx only. Labeled as: a. Product Code LXM-13; b. Product Code LXM-14; c. Product Code LXM-15; d. Product Code LXM-16; 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 eq

a. Product Code LXM-13, Part No. 4549-13, GTIN 00855106005394; b. Product Code LXM-14, Part No. 4549-14, GTIN 00855106005400; c. Product Code LXM-15, Part No. 4549-15, GTIN 00855106005417; d. Product Code LXM-16, Part No. 4549-16, GTIN 00855106005424; Lot No. 6100 through 14055, 15286, 15287, 15314, 15315, 15317, and 16557

Lot Numbers:
LXM-13
LXM-14
LXM-15
LXM-16

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 79822
Status: Resolved
Manufacturer: Torax Medical, Inc.
Manufactured In: United States
Units Affected: 5 products (9,131 devices in total)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.