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 suppression therapy (i.e. proton pump inhibitors or equivalent) in the management of their GERD.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Torax Medical, Inc.
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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 suppression therapy (i.e. proton pump inhibitors or equivalent) in the management of their GERD.
Product Codes/Lot Numbers:
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 Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2037-2018
Related Recalls
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.
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.
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.