Recall Z-2039-2018— Torax Medical, Inc.
Class II · Terminated
Class II FDA medical device recall by Torax Medical, Inc., initiated 2018-04-20, terminated 2020-11-04. FDA's recall record names no specific 510(k) clearance for this event. 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 (i.e. proton pump inhibitors or equivalent) in the management of their GERD.. Reason: 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..
- Recalling firm
- Torax Medical, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-04-20
- Terminated
- 2020-11-04
- Firm location
- Shoreview, MN, United States
Product description
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 (i.e. proton pump inhibitors or equivalent) in the management of their GERD.
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.
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