Z-1610-2014 Class II Terminated
FDA device recall Z-1610-2014 was initiated by Ortho Development Corporation on April 1, 2014 and is designated Class II. Reason for recall: A femoral component containing pegs was found in a box for the pegless version. The recall status is terminated (terminated July 14, 2014). Affected quantity: 5.
Recall Details
- Product Type
- Devices
- Report Date
- May 21, 2014
- Initiation Date
- April 1, 2014
- Termination Date
- July 14, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5
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.
Distribution Pattern
US Nationwide Distribution in the states of NV, and AZ.
Code Information
Lot No. A131876