FDAFDA · Food and drugs·Recall number Z-1380-2013
UKNEE Patella,small 2401-1010 UKNEE Patella,medium 2401-1020 UKNEE Patella,large 2401-1030 UKNEE Patella,X-large 2401-1040 UKNEE Onset Patella, 3 pegs, x-small 2403-1010 UKNEE Onset Patella, 3 pegs, small 2403-1020 UKNEE Onset Patella, 3 pegs, medium 2403-1030 UKNEE Onset Patella, 3 pegs, large 2403-1040 UKNEE Onset Patella, 3 pegs,X-large 2403-1050 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
- Catalog No. 2401-1010 2401-1020 2401-1030 2401-1040 2403-1010 2403-1020 2403-1030 2403-1040 2403-1050
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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