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Recall Observatory FDA recall evidence

Device 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

Z-2086-2016

April 29, 2016

Class II

Product summary

Firm
Integra LifeSciences Corp.
Event
Event 74173
Status
Terminated
Classification
Class II
Quantity
12 units
Official record key
device-enforcement:Z-2086-2016

Official wording

Reason: 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.

Code information: Cat No. 10207205, Lot: QJ0248

Distribution pattern: NC and PA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.