Z-1512-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 2, 2018
- Initiation Date
- January 12, 2018
- Termination Date
- May 7, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6 units of catalog 5521-B-400
Product Description
Knee Prosthesis, Sterile, Single-Use devices Product Usage: The knee system devices are intended for use in revision total knee arthroplasty to alleviate pain and restore function
Reason for Recall
Firm became aware that the specific product/lot combinations referenced above may contain the incorrect size implant from what is labeled on the box.
Distribution Pattern
Affected products were sent to three medical facilities. Affected product will be returned to the manufacturer for disposition.
Code Information
Catalog 5521-B-300, lot code ATV7IA Catalog 5521-B-400, lot code ATY40A