Integra LifeSciences Corp.: Medical Device Recall in 2016 - (Recall #: Z-2086-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: April 29, 2016

Date Posted: July 6, 2016

Recall Number: Z-2086-2016

Event ID: 74173

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.

Status: Terminated

Product Quantity: 12 units

Code Information:

Cat No. 10207205, Lot: QJ0248

Distribution Pattern:

NC and PA

Voluntary or Mandated:

Voluntary: Firm initiated