Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Cadence Size 5 Left Tibial Tray Implant, designed to treat ankle arthritis through replacement of the ankle joint with a prosthesis, thereby reducing pain, restoring alignment, and allowing for movement at the replaced joint. Catalog Number: 10207205; Lot Number #QJ0248

FDA Recall Z-2086-2016 · Posted None

Recalling FirmIntegra LifeSciences Corp.
Recall StatusTerminated
Product CodeHSN
Date Initiated2016-04-29
Date Terminated2016-10-19
Product Quantity12 units

Reason for Recall

As a result of an internal review of all labeling for the Cadence System, it was determined that the outer package label for the Size 5 Left Tibial Tray Implant reflects the material composition incorrectly. The labeling incorrectly reflects the material as Cobalt Chromium instead of Titanium.

Firm Action

On 4/29/16, US consignees were notified by electronic mail delivered by traceable method.

Root Cause

Labeling mix-ups

Distribution Pattern

NC and PA

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑