Foundation Knee System, non-porous Femur Size 8, Right
This recall has been terminated (originally issued July 30, 2003).
- Recall Initiated
- April 24, 2003
- Posted
- July 30, 2003
- Terminated
- July 29, 2003
- Recall Number
- Z-1069-03
- Quantity
- 14 unimplanted units
- Firm Location
- Austin, TX
- Official Source
- View on FDA website ↗
Reason for Recall
Product container was labeled incorrectly indicating left femur instead of right.
Distribution
PA, TX, MA, FL, NV, AZ, and France and Saudi Arabia
Lot / Code Info
Lot numbers 811761, 815241, 815251, 817891, 834781, 835291, 838201, 850611
Root Cause
Other
Action Taken
The firm recalled non-implanted devices. The firm initiated the recall on 04/23/2003 via phone to sales representatives and foreign distributors.