Z-2038-2018Class II

LINX Reflux Management System, Implant Clasp, 12-17 Bead, 0.7T, Product Code LXC-xx, sterile, Rx only...

Name: Z-2038-2018 LINX Reflux Management System, Implant Clasp, 12-17 Bead, 0.7T, Product Code LXC-xx, sterile, Rx only...
Creator: Torax Medical, Inc.
Published: 2018-04-20
License: https://open.fda.gov/license/

Torax Medical, Inc. / initiated 2018-04-20 / Terminated / root cause: manufacturing process

FDA source

Torax Medical, Inc. began a recall of 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... on 2018-04-20. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2038-2018
Classification: Class II
Status: Terminated
Initiated: 2018-04-20
Posted: 2018-05-31
Terminated: 2020-11-04
Recalling firm: Torax Medical, Inc.
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; 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 code: LEI Implant, Anti-Gastroesophageal Reflux
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm, Consignees Torax Medical Inc., sent an "URGENT: FIELD SAFETY NOTICE (REMOVAL)" letter mailed on approximately 04/20/2018 (US consignees and physicians) and 04/23/2018 (OUS consignees and physicians). The letter described the product, problem and actions to be taken. The customers were instructed to examine inventory for affected product, quarantine any affected product, communicate the issue to all relevant operating room or materials management personnel, forward the recall information to facilities where the product may have been forwarded to, complete the Business Reply Form confirming receipt of this notice and return it to Torax Medical, Inc. within three (3) business days via email at [email protected]; ( return the BRF even if you do not have the product lot subject to this recall.), and arrange the return of any affected product on hand. Additionally, a recall notification will be sent to sent to physicians outlining the reason for recall and to advise them to monitor their patients. Question regarding the recall can be directed to the Customer Support Cetner at 1-877-384-4266, which is open Monday through Friday, 7:30 AM to 6:30 PM ET.
Quantity in commerce: 9,131 devices in total
Distribution: Worldwide Distribution: US (nationwide) in states of: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY; and in countries of: Austria, France, Germany, Italy, Scotland, Spain, Switzerland, United Kingdom.
Product codes and lots: 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, 15287, 15314, 15315, 15317, and 16557

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2038-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2037-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-31
Z-2038-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-31
Z-2039-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-31
Z-2040-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-31
Z-2041-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-31

Product code LEI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)