Reported Jun 6, 2018 · Terminated
LINX Reflux Management System, Implant Clasp, 12-17 Bead, 0.7T, Product Code LX-xx, sterile, Rx only. Labeled as: a.…
Torax Medical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Torax Medical, Inc. · 4188 Lexington Ave N · Shoreview, MN · 55126-6106
Is this the product you have?
6 of 6 products
| Model / number | Product as published |
|---|---|
LX-12 | — |
LX-13 | — |
LX-14 | — |
LX-15 | — |
LX-16 | — |
LX-17 | Laparoscopic, fundic-sparing anti-reflux procedure indicated for patients diagnosed with Gastroesophageal Reflux Disease (GERD) as defined by abnormal pH testing, and who are seeking an alternative to continuous acid suppression therapy (i.e. proton pump inhibitors or equivalent) in the management of their GERD. |
- Lot codes and dates
6 of 6 products
Products covered by this recall Model / number Product as published 00855106005073Product Code LX-12, Part No. 2684-12 00855106005080Product Code LX-13, Part No. 2684-13 00855106005097Product Code LX-14, Part No. 2684-14 00855106005103Product Code LX-15, Part No. 2684-15 00855106005110Product Code LX-16, Part No. 2684-16 00855106005127Product Code LX-17, Part No. 2684-17, ; Lot No. 6100 through 14055, 15286, 15287, 15314, 15315, 15317, and 16557 - Amount recalled
- 9,131 devices in total
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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