Device product
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.
Z-1380-2013
Product summary
- Event
- Event 64588
- Status
- Terminated
- Classification
- Class II
- Quantity
- 57 units
- Official record key
device-enforcement:Z-1380-2013
Official wording
Reason: 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.
Code information: Catalog No. 2401-1010 2401-1020 2401-1030 2401-1040 2403-1010 2403-1020 2403-1030 2403-1040 2403-1050
Distribution pattern: Nationwide Distribution including the states of CA, MD, TX, NV, and WI.
Derived failure modes
-
Unknown
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.