The Recall Desk
SevereFDA (Devices)·Z-2041-2018·Announced 2018-06-06

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.

What this means for you

Illness, injury, or structural failure has been reported. 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.
Category
Medical Device — Implantable Device
Hazard
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

Distributed nationwide across the United States.

The notice also names 47 states specifically:

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.

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Same hazard · structural failure

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