FDAFDA · Food and drugs·Recall number Z-1384-2013
Co-Cr cancellous bone screw,15mm Co-Cr cancellous bone screw,20mm Co-Cr cancellous bone screw,25mm Co-Cr cancellous bone screw,30mm Co-Cr cancellous bone screw,35mm Co-Cr cancellous bone screw,40mm Variety of hip and knee implants and instruments, multiple uses.
Published June 5, 2013 · Recall initiated: February 20, 2013
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 recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physician and for every surgery.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Orthopedic Alliance LLC
- Distributor
- Nationwide Distribution including the states of CA, MD, TX, NV, and WI.
- Lot
- Item No. 5201-6715 5201-6720 5201-6725 5201-6730 5201-6735 5201-6740
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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