Z-2086-2016Class II

Cadence Size 5 Left Tibial Tray Implant, designed to treat ankle arthritis through replacement of the ankle...

Name: Z-2086-2016 Cadence Size 5 Left Tibial Tray Implant, designed to treat ankle arthritis through replacement of the ankle...
Creator: Integra LifeSciences Corp.
Published: 2016-04-29
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2016-04-29 / Terminated / root cause: labeling and UDI

FDA source

Integra LifeSciences Corp. began a recall of Cadence Size 5 Left Tibial Tray Implant, designed to treat ankle arthritis through replacement of the ankle joint with a prosthesis, thereby reducing pain... on 2016-04-29. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2086-2016
Classification: Class II
Status: Terminated
Initiated: 2016-04-29
Posted: 2016-06-29
Terminated: 2016-10-19
Recalling firm: Integra LifeSciences Corporation
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
Product code: HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: On 4/29/16, US consignees were notified by electronic mail delivered by traceable method.
Quantity in commerce: 12 units
Distribution: NC and PA
Product codes and lots: Cat No. 10207205, Lot: QJ0248

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2086-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2086-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-06	2016-06-29

Product code HSN

K151459Class IIIntegra Total Ankle Replacement SystemAscension Orthopedics / cleared 2015-08-31

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)