Recall Z-2296-2016— Integra LifeSciences Corp.

Name: FDA recall Z-2296-2016
Creator: U.S. Food and Drug Administration
Published: 2016-07-01

Class II · Terminated

Class II FDA medical device recall by Integra LifeSciences Corp., initiated 2016-07-01, terminated 2016-12-16. It names one FDA 510(k) clearance: K140463. Product: Integra External Fixation System Rocker Bottom Model # 12225400. For use in the treatment of bone conditions amenable to treatment by the use of external fixation.. Reason: The silicone insert embedded in the rocker bottom has the potential to become dislodged or loose from the rocker bottom mold..

Recalling firm: Integra LifeSciences Corp.
Classification: Class II
Status: Terminated
Initiated: 2016-07-01
Terminated: 2016-12-16
Firm location: Plainsboro, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K140463 — INTEGRA EXTERNAL FIXATION SYSTEMAscension Orthopedic·cleared 2014-10-10

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 External Fixation System Rocker Bottom Model # 12225400. For use in the treatment of bone conditions amenable to treatment by the use of external fixation.

Reason for recall

The silicone insert embedded in the rocker bottom has the potential to become dislodged or loose from the rocker bottom mold.

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