Medacta Quadra Trial Broach size 0 part # 01.10.10.045, for use with the Medacta Total Hip Prosth...
FDA Recall #Z-0791-2013 — Class II — December 17, 2012
Product Description
Medacta Quadra Trial Broach size 0 part # 01.10.10.045, for use with the Medacta Total Hip Prosthesis System. Product Usage - used to broach the intramedullary canal of the femur in order to create space for the femoral stem during a hip replacement surgery.
Reason for Recall
The tip of the Quadra Trial Broach size 0, broke during a surgery.
Recalling Firm
Medacta Usa Inc — Camarillo, CA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
26 pieces U.S.A. (226 pieces Worldwide)
Distribution
US Nationwide Distribution including the states of Arizona, California, Idaho, Illinois, North Carolina, Ohio, Utah, Washington and US Virgin Islands
Code Information
Lot/Unit Codes: 075023, 075064, 084000, 084001, 084326, 084743, 084815, 085202, 085455
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated