Cadence Size 5 Left Tibial Tray Implant — Class II medical device recall Z-2086-2016
Terminated recall by Integra LifeSciences Corp., reported 2016-07-06, distributed in NC, PA. As a result of an internal review of all labeling for the Cadence System, it was determined that the outer pac
| Recall number | Z-2086-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Integra LifeSciences Corp., Plainsboro, NJ, United States |
| Recall initiated | 2016-04-29 |
| Classified | 2016-06-29 |
| Reported by FDA | 2016-07-06 |
| Terminated | 2016-10-19 |
| Distributed | NC, PA |
| Quantity | 12 units |
| Reason classes | labeling |
| Lot numbers | QJ0248 |
| Model numbers | 10207205 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2086-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.