Device product
PS-C Femoral Nonporous Rt Sz 6, Model Number 161-1604 Component of the Balanced Knee System and Balanced Knee Revision System, for total knee arthroplasty procedures.
Z-1610-2014
Product summary
- Event
- Event 68029
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5
- Official record key
device-enforcement:Z-1610-2014
Official wording
Reason: A femoral component containing pegs was found in a box for the pegless version.
Code information: Lot No. A131876
Distribution pattern: US Nationwide Distribution in the states of NV, and AZ.
Derived failure modes
-
Unknown
A femoral component containing pegs was found in a box for the pegless version.