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.
Reported: May 21, 2014 Initiated: April 1, 2014 #Z-1610-2014
Product Description
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.
Reason for Recall
A femoral component containing pegs was found in a box for the pegless version.
Details
- Recalling Firm
- Ortho Development Corporation
- Units Affected
- 5
- Distribution
- US Nationwide Distribution in the states of NV, and AZ.
- Location
- Draper, UT
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Ortho Development Corporation. Units affected: 5.
Why was this product recalled? ▼
A femoral component containing pegs was found in a box for the pegless version.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 21, 2014. Severity: Moderate. Recall number: Z-1610-2014.
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