Recall Z-2374-2012— Omni Life Science

Name: FDA recall Z-2374-2012
Creator: U.S. Food and Drug Administration
Published: 2012-08-09

Class II · Terminated

Class II FDA medical device recall by Omni Life Science, initiated 2012-08-09, terminated 2013-01-10. It names one FDA 510(k) clearance: K094017. Product: Omnilife Science Apex Knee System Modular Tibia Augment, Size 5 x 4mm Ref: KC-54050. The Apex Knee System is intended for use as a primary or revision total knee replacement.. Reason: The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility.

Recalling firm: Omni Life Science
Classification: Class II
Status: Terminated
Initiated: 2012-08-09
Terminated: 2013-01-10
Firm location: East Taunton, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K094017 — TIBIAL BASEPLATE AUGMENT MODEL KC-22118, KC-22128, KC-22138, KC-22148, KC-22158Omni Life Science, Inc.·cleared 2010-03-05

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

Omnilife Science Apex Knee System Modular Tibia Augment, Size 5 x 4mm Ref: KC-54050. The Apex Knee System is intended for use as a primary or revision total knee replacement.

Reason for recall

The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility

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