Torax Medical recalls LINX Reflux Management System implants with possible bead separation causing device discontinuity. Affected products include specific product codes and lot numbers.
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.
Torax Medical is recalling LINX Reflux Management System implants that may have a bead component separating from the wire link, potentially causing the device to become discontinuous. This could affect patients with GERD who received the implant under a doctor's prescription.
The device may have a bead component that separates from the wire link, creating a discontinuous or open LINX device. This could lead to the implant no longer functioning properly as intended for reflux management.
Patients who received the LINX Reflux Management System implant for GERD treatment between the specified dates and lot numbers. Those with the product codes LXC-12 through LXC-17 are most at risk.
Check if your LINX Reflux Management System implant has product codes LXC-12 through LXC-17, or lot numbers 6100 through 14055, 15286, 15287, 15314, 15315, 15317, and 16557.
Review your implant's product code (LXC-12 to LXC-17) and lot number to confirm if it's affected.
It's a laparoscopic, fundic-sparing anti-reflux procedure for patients diagnosed with GERD who need an alternative to continuous acid suppression therapy.
Product codes LXC-12 through LXC-17 with specific lot numbers: 6100 through 14055, 15286, 15287, 15314, 15315, 15317, and 16557.
No action is needed if your implant's product code and lot number are not listed in the recall.
We’ve drafted a message you can send Torax Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2038-2018 — Torax Medical Torax Medical Hello, I own a Torax Medical that is covered by recall Z-2038-2018 from Torax Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
