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U.S. Department of Health and Human Services

Class 2 Device Recall LINX Reflux Management System

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  Class 2 Device Recall LINX Reflux Management System see related information
Date Initiated by Firm April 20, 2018
Create Date May 31, 2018
Recall Status1 Open3, Classified
Recall Number Z-2037-2018
Recall Event ID 79822
PMA Number P100049 
Product Classification Implant, anti-gastroesophageal reflux - Product Code LEI
Product LINX Reflux Management System, Implant Suture, 12-17 Bead, 0.7T, Product Code LS-xx, sterile, Rx only. Labeled as:

a. Product Code LS-12;
b. Product Code LS-13;
c. Product Code LS-14;
d. Product Code LS-15;
e. Product Code LS-16;
f. Product Code LS-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.
Code Information a. Product Code LS-12, Part No. 2170-6, GTIN 00855106005011;  b. Product Code LS-13, Part No. 2170-7, GTIN 00855106005028;  c. Product Code LS-14, Part No. 2170-8, GTIN 00855106005035;  d. Product Code LS-15, Part No. 2170-9, GTIN 00855106005042;  e. Product Code LS-16, Part No. 2170-10, GTIN 00855106005059;  f. Product Code LS-17, Part No. 2170-11, GTIN 00855106005066;   Lot No. 6100 through 14055, 15286, 15287, 15314, 15315, 15317, and 16557
Recalling Firm/
Manufacturer
Torax Medical, Inc.
4188 Lexington Ave N
Shoreview MN 55126-6106
For Additional Information Contact
877-384-4266
Manufacturer 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.
FDA Determined
Cause 2
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 brf@toraxmedical.com; ( 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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA Database PMAs with Product Code = LEI and Original Applicant = TORAX MEDICAL
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