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

Recall Z-1175-2019 — Talar Dome Total Ankle Prosthesis , Sloped, Size 3, Left, Product No. LJV193T

U.S. FDA — Device Enforcement · United States · 2019-03-08 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1175-2019
Date of alert
2019-03-08
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Integra LifeSciences Corp.
Product category
device
Product type
Devices
Reported risk: The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box and inner pouch) and IFU
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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