FDAFDA · Food and drugs·Recall number Z-1011-2018
Vanguard CR Porous Femoral 62.5mm (Left Femur) For use in total knee arthroplasty
Published March 21, 2018 · Recall initiated: October 3, 2017
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 affected products are labeled as a 62.5mm LEFT Femur; however, the contents are a Vanguard 70mm RIGHT Femur.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Zimmer Biomet, Inc.
- Distributor
- US Distribution to states of: FL, WI, MD, MO, and MI.
- Lot
- Item #183066/Lot 132900; UDI-(01) 0088030427068 (17) 270816 (10) 132900
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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