Z-2038-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 6, 2018
- Initiation Date
- April 20, 2018
- Termination Date
- November 4, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9,131 devices in total
Product Description
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.
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.
Distribution Pattern
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.
Code Information
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