FDAFDA · Food and drugs·Recall number Z-1610-2014
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.
Published May 21, 2014 · Recall initiated: April 1, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
A femoral component containing pegs was found in a box for the pegless version.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Ortho Development Corporation
- Distributor
- US Nationwide Distribution in the states of NV, and AZ.
- Lot
- Lot No. A131876
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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