FDA Device recall Z-2086-2016
Cadence Size 5 Left Tibial Tray Implant, designed to treat ankle arthritis through replacement of the ankle joint with a prosthesis, thereb…
- FDA Device
- Class II
- terminated
- Published 2016-07-06
On 2016-07-06 the FDA classified a Class II recall of Cadence Size 5 Left Tibial Tray Implant, designed to treat ankle arthritis through replacement of the ankle joint with a prosthesis, thereb… by Integra Lifesciences, citing 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 mater….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2086-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-04-29 |
| Published | 2016-07-06 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Integra Lifesciences |
| Distribution | NC, PA |
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
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.
Identifiers
| code_info | Cat No. 10207205, Lot: QJ0248 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2086-2016%22
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