Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2038-2018 — LINX Reflux Management System, Implant Clasp, 12-17 Bead, 0.7T, Product Code LXC-xx, sterile, Rx only. Labeled as: a. Product Code LXC-12; b. Product Code LXC-13; c. Product Code LXC-14; d. Product Code LXC-15; e. Product Code LXC-16; f. Product Code LXC-17; Laparoscopic, fun

U.S. FDA — Device Enforcement · United States · 2018-04-20 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2038-2018
Date of alert
2018-04-20
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Torax Medical, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00855106005134
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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