PlainRecalls
FDA Devices Moderate Class II 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

Reported: July 6, 2016 Initiated: April 29, 2016 #Z-2086-2016

Product Description

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

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.

Details

Units Affected
12 units
Distribution
NC and PA
Location
Plainsboro, NJ

Frequently Asked Questions

What product was recalled?
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. Recalled by Integra LifeSciences Corp.. Units affected: 12 units.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 6, 2016. Severity: Moderate. Recall number: Z-2086-2016.