LINX Reflux Management System recall
LINX Reflux Management System, Implant Clasp, 13-17 Bead, 1.5T, Product Code LXMC-xx, sterile, Rx only. Labeled as: a. Product Code LXMC-13; b.…
Why was LINX Reflux Management System recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
a. Product Code LXMC-13, Part No. 4550-13, GTIN 00855106005332; b. Product Code LXMC-14, Part No. 4550-14, GTIN 00855106005349; c. Product Code LXMC-15, Part No. 4550-15, GTIN 00855106005356; d. Product Code LXMC-16, Part No. 4550-16, GTIN 00855106005363; e. Product Code LXMC-17, Part No. 4550-17, GTIN 00855106005370; Lot No. 6100 through 14055, 15286, 15287, 15314, 15315, 15317, and 16557
- Product
- LINX Reflux Management System, Implant Clasp, 13-17 Bead, 1.5T, Product Code LXMC-xx, sterile, Rx only. Labeled as: a. Product Code LXMC-13; b.…
- Recalling firm
- Torax Medical, Inc.
- Quantity
- 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.
- Recall date
- June 6, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)