FDAFDA · Food and drugs·Recall number Z-2302-2012
3DKnee e+ Tibial Insert - HXLPE-VE, Sterile, Material: Highly cross linked vitamin E PE, Sz 2/9mm. The insert is intended to more closely match the kinematics of the knee, allowing some rotation along the medial condyle and increased congruency along lateral condyle. This insert is to be used along with the other components that comprise the 3DKnee System.
Published September 5, 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 firm is recalling one lot of 392-09-706, 3DKnee e+ Tibial insert, 9 mm, Size 6, Right. The shelf life labeling of specific lots for a component were found to be incorrect and were found to be expired.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Encore Medical, Lp
- Distributor
- Worldwide Distribution including Venezuela.
- Lot
- Model Number 392-09-706, Lot Number 59602519
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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