Recalls / —
—#146597
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
- FDA product code
- HSN — Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
- Device class
- Class 2
- Medical specialty
- Orthopedic
- 510(k) numbers
- K151459
- Affected lot / code info
- Cat No. 10207205, Lot: QJ0248
Why it was recalled
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 (FDA determination)
Labeling mix-ups
Action the firm took
On 4/29/16, US consignees were notified by electronic mail delivered by traceable method.
Recalling firm
- Firm
- Integra LifeSciences Corp.
- Address
- 311 Enterprise Dr, Plainsboro, New Jersey 08536-3344
Distribution
- Distribution pattern
- NC and PA
Timeline
- Recall initiated
- 2016-04-29
- Terminated
- 2016-10-19
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #146597. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.