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Integra LifeSciences Corp. recalls Cadence Size 5 Left Tibial Tray Implant, designed to treat ankle arthritis through replacement of the ankle joint with a
Recalled July 6, 2016 · FDA recall Z-2086-2016 · Integra LifeSciences
Hazard
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. · FDA Class II
Units
12 units
Sold at
NC and PA
Description
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.
Product
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
Manufacturer(s)
Integra LifeSciences Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →