Z-2037-2018 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 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.
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 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