FDAFDA · Food and drugs·Recall number Z-2370-2012
Omnilife Science Apex Knee System Modular Tibia Augment, Size 1 x 4mm Ref: KC-54010. The Apex Knee System is intended for use as a primary or revision total knee replacement.
Published September 19, 2012 · Recall initiated: August 9, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Omni Life Science
- Distributor
- Worldwide Distribution-USA (nationwide including the states of CO, NY, OK, PA, UT, VA, and WI, and the countries of Spain and the Netherlands.
- Lot
- Lot Numbers: 8361, 8525, 8894,8930, 8975, 9167, 9169, 10220, 10313, 10717, 11547
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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