Torax Medical recalls LINX Reflux Management System implants with specific product codes due to potential bead separation causing device discontinuity. Affected patients should contact for guidance.
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 with certain product codes because a bead component might separate from the device, causing it to become disconnected. This could affect patients who have had the procedure for GERD.
The device may have a bead component that separates from the wire link, causing the LINX system to become disconnected. This could lead to the device no longer functioning properly.
Patients who received the LINX Reflux Management System implant for GERD treatment with the specified product codes are affected. Those who have the implant are most at risk.
Check the product code on the implant, which is labeled as LXMC-13 through LXMC-17. The affected units were sold with specific lot numbers between 6100 and 14055, 15286, 15287, 15314, 15315, 15317, and 16557.
Reach out to Torax Medical for specific guidance on whether your implant is affected and next steps.
No, only specific product codes (LXMC-13 to LXMC-17) and certain lot numbers are affected.
The LINX device may become disconnected, which could affect its function for GERD management.
The recall does not specify removal; contact Torax Medical for guidance.
We’ve drafted a message you can send Torax Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2039-2018 — Torax Medical Torax Medical Hello, I own a Torax Medical that is covered by recall Z-2039-2018 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.