Recall Z-1192-2017— Integra LifeSciences Corp.

Name: FDA recall Z-1192-2017
Creator: U.S. Food and Drug Administration
Published: 2017-01-20

Class II · Terminated

Class II FDA medical device recall by Integra LifeSciences Corp., initiated 2017-01-20, terminated 2017-03-30. It names one FDA 510(k) clearance: K151459. Product: Integra Cadence Total Ankle System. Reason: Posterior tibial fractures have been reported..

Recalling firm: Integra LifeSciences Corp.
Classification: Class II
Status: Terminated
Initiated: 2017-01-20
Terminated: 2017-03-30
Firm location: Plainsboro, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K151459 — Integra Total Ankle Replacement SystemAscension Orthopedics·cleared 2015-08-31

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Integra Cadence Total Ankle System

Reason for recall

Posterior tibial fractures have been reported.

Data sourced from openFDA. This site is unofficial and independent of the FDA.