Integra LifeSciences Corp. recalls Cadence Size 5 Left Tibial Tray Implant, designed to treat ankle arthritis through replacement of the ankle joint with…

Recall date

April 29, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2086-2016

FDA classification

Class II

Brand / firm

Integra LifeSciences Corp.

Sold / distributed

NC and PA

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What 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