FDAFDA · Food and drugs·Recall number Z-2086-2014
NOVATION Femoral Stem, Tapered Extended offset, plasma- coated, press fit. Catalog number 160-01-13 intended to be implanted to replace a hip joint with our without bone cement.
Published July 30, 2014 · Recall initiated: March 7, 2014
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 femoral stem is lacking specified plasma coating.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Exactech, Inc.
- Distributor
- Worldwide Distribution including Spain, Greece and Japan
- Lot
- Serial Numbers: 2910243, 2910244, 2910245, 2910246, 2910247, 2910248, 2910249, 2910250, 2910251, and 2910252
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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