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.
This recall has been terminated (originally issued May 13, 2014).
- Company
- Ortho Development Corporation
- Recall Initiated
- April 1, 2014
- Posted
- May 13, 2014
- Terminated
- July 14, 2014
- Recall Number
- Z-1610-2014
- Quantity
- 5
- Firm Location
- Draper, UT
- Official Source
- View on FDA website ↗
Reason for Recall
A femoral component containing pegs was found in a box for the pegless version.
Distribution
US Nationwide Distribution in the states of NV, and AZ.
Lot / Code Info
Lot No. A131876
Root Cause
Process control
Action Taken
Ortho notified customers via email and phone calls on April 1, 2014. Customers were asked to return product in inventory.
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