The United States Food and Drug Administration (FDA) has issued medical device safety alerts concerning M/L Taper with Kinectiv Technology Femoral Stems and Necks, manufactured by Zimmer.
The manufacturer has initiated a voluntary recall of 64 lots (752 implants total) of M/L Taper with Kinectiv femoral stems and modular necks due to higher than allowed cytotoxicity levels found with the product.
The manufacturer found a process monitoring failure that led to higher than expected amounts of manufacturing residues left on the devices. These residues can cause serious adverse health issues including allergic reactions, pain, infections, or death. Use of these products may require the need for a revision surgery to replace the affected implant.
According to the local supplier, the affected products are not distributed in Hong Kong.
For details, please refer to the FDA websites:
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1699-2015&w=06172015&lang=eng
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm452012.htm
http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm451936.htm
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 23 June 2015