FDA-Device2016-07-06Class II
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
Integra LifeSciences Corp.
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.
Sold states
NC and PA
Affected count
12 units
Manufactured in
311 Enterprise Dr, Plainsboro, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2086-2016Don't want to check this manually?
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