Torax Medical Recalls LINX Reflux Management System Implant Clasps
Torax Medical is recalling LINX Reflux Management System implant clasps because a manufacturing defect may allow a bead to separate from the wire link, potentially rendering the device open or discontinuous.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the defect involves a structural failure of an implanted medical device that could render it non-functional or open, meeting the criteria for a Severe rating.
Plain-English summary
Torax Medical, Inc. is recalling 9,131 units of the LINX Reflux Management System, Implant Clasp, 13-16 Bead, 1.5T. The affected devices are sterile, prescription-only medical implants used in laparoscopic, fundic-sparing anti-reflux procedures for patients with Gastroesophageal Reflux Disease (GERD). The recall covers specific product codes (LXM-13, LXM-14, LXM-15, and LXM-16) and lot numbers ranging from 6100 through 14055, as well as lots 15286, 15287, 15314, 15315, 15317, and 16557.
The recall is being issued due to a possible out-of-specification condition that may allow a bead component to separate from an adjacent wire link. This defect may result in a discontinuous or open LINX device. The affected devices were distributed nationwide in the United States and in several countries, including Austria, France, Germany, Italy, Scotland, Spain, Switzerland, and the United Kingdom.
Patients who have had this specific LINX implant placed should contact their healthcare provider to discuss the recall and determine if any follow-up action is necessary. The devices are prescription-only, and patients should not attempt to remove or alter the implant themselves.
The recalled product
- 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…
- Manufacturer
- Torax Medical, Inc.
- Affected units
- 9,131
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (19)
- 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
Distribution
Part of a larger recall action
This product is one of 5 recalled by Torax Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 5 products in this recall →Related recalls
Same manufacturer · Torax Medical, Inc.
See all →- SevereTorax Medical Recalls LINX Reflux Management System Implant Clasps
FDA (Devices) · 2018-06-06
- ModerateTorax Medical Recalls LINX Reflux Management System Devices
FDA (Devices) · 2018-06-06
- SevereTorax Medical Recalls LINX Reflux Management System Implant Clasps
FDA (Devices) · 2018-06-06
- HighTorax Medical Recalls LINX Reflux Management System Implant Sutures
FDA (Devices) · 2018-06-06
Same hazard · structural failure
See all →- High
- ModerateQuantum Ops Recalls ADAPTABLE Beach Chair Surgical Patient Positioners
FDA (Devices) · 2026-10-14
- SevereMedline Bariatric Rollator Recalled Due to Front Wheel Assembly Disconnect Risk
FDA (Devices) · 2026-10-14
- SevereMedline Bariatric Rollator Recalled Due to Front Wheel Detachment Risk
FDA (Devices) · 2026-10-14
- SeverePacearth Recalls Swing Seats Due to Serious Injury Risk from Falling
CPSC · 2026-10-08
Similar recalls
- SevereX Spine Systems Recalls Calix T PEEK Lumbar System TLIF Rasps
FDA (Devices) · 2016-10-26
- HighSignature Laparoscopic Sharp Tooth Grasper Insulation Defect Recall
FDA (Devices) · 2025-06-11
- HighSignature Laparoscopic Allis Clamp Grasper with Rotating Shaft Recalled
FDA (Devices) · 2025-06-11
- HighX Spine Systems Recalls Calix P PEEK Lumbar System PLIF Rasps
FDA (Devices) · 2016-10-26
- LowTelefax Medical Recalls Weck EFx Fascial Closure System for Labeling Error
FDA (Devices) · 2016-08-24
- HighSignature Laparoscopic Bullet Tip Grasper Instrument Insulation Defect Recall
FDA (Devices) · 2025-06-11