Torax Medical recalls LINX Reflux Management System implants with possible bead separation causing device discontinuity. Affected products include specific product codes and lot numbers for GERD treatment.
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 open or discontinuous. This could affect patients with GERD who have received the implant as an alternative to long-term acid suppression therapy.
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 GERD management.
Patients who received the LINX Reflux Management System implant for GERD treatment between the specified dates and lot numbers are affected. Those with the product codes LX-12 through LX-17 are most at risk.
Check the product code on the device label, which should be LX-12 through LX-17. Also verify the lot numbers listed: 6100 through 14055, 15286, 15287, 15314, 15315, 15317, and 16557.
Look for the product code on the device label, which should be LX-12 through LX-17.
Confirm the lot numbers match those listed: 6100 through 14055, 15286, 15287, 15314, 15315, 15317, and 16557.
It's a laparoscopic procedure for patients diagnosed with GERD who need an alternative to long-term acid suppression therapy.
Product codes LX-12 through LX-17 with specific lot numbers listed in the recall notice.
The recall does not require immediate action; check your product code and lot numbers to see if you are affected.
We’ve drafted a message you can send Torax Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2040-2018 — Torax Medical Torax Medical Hello, I own a Torax Medical that is covered by recall Z-2040-2018 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.
