Integra Cadence Total Ankle System
FDA Recall Z-1192-2017 · Posted 2017-02-11
Recalling FirmIntegra LifeSciences Corp.
Recall StatusTerminated
Product CodeHSN
Date Initiated2017-01-20
Date Terminated2017-03-30
Product Quantity944 units
Reason for Recall
Posterior tibial fractures have been reported.
Firm Action
The firm intends to update the surgical technique only. No product will be returned. US and non-US consignees were notified by letter delivered by traceable fax or e-mail on 01/20/2017.
Root Cause
Use error
Distribution Pattern
Nationwide
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.