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 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 adjacent wire link due to an out-of-specification condition. This could cause the LINX device to become discontinuous, meaning it might not function properly as intended.
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 LS-12 through LS-17 are most at risk.
Check your LINX Reflux Management System implant label for product codes LS-12 through LS-17. The affected products were sold with lot numbers 6100 through 14055, 15286, 15287, 15314, 15315, 15317, and 16557.
Look for product codes LS-12 through LS-17 on the implant label to determine if your device is affected.
Yes, this recall applies to patients who received the LINX Reflux Management System implant for GERD treatment as an alternative to long-term acid suppression therapy.
Product codes LS-12 through LS-17 are affected, with specific lot numbers listed in the recall notice.
No action is needed if your device does not have the affected product codes or lot numbers.
We’ve drafted a message you can send Torax Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2037-2018 — Torax Medical Torax Medical Hello, I own a Torax Medical that is covered by recall Z-2037-2018 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.
