The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-2038-2018·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 discontinuous or open.

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. According to the rubric, FDA Class II recalls involving significant injury or structural defects are rated as Severe (4). The potential for the device to become discontinuous or open represents a significant structural defect in an implanted medical device.

Plain-English summary

Torax Medical, Inc. is recalling 9,131 units of the LINX Reflux Management System, Implant Clasp, 12-17 Bead, 0.7T. The affected product codes are LXC-12, LXC-13, LXC-14, LXC-15, LXC-16, and LXC-17. The devices are sterile, prescription-only medical implants indicated for patients with Gastroesophageal Reflux Disease (GERD) who are seeking an alternative to continuous acid suppression therapy.

The recall is due to a possible out-of-specification condition that may allow a bead component to separate from an adjacent wire link. This condition may result in a discontinuous or open LINX device. The affected lots include numbers 6100 through 14055, 15286, 15287, 15314, 15315, 15317, and 16557.

The 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 received this implant should contact their healthcare provider for evaluation and guidance regarding the recall.

The recalled product

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…
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 (20)

  • 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

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 →

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