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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
Quadra Trial Broach size 0		see related information
Date Posted February 07, 2013
Recall Number Z-0791-2013
Product 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.
Code Information Lot/Unit Codes: 075023, 075064, 084000, 084001, 084326, 084743, 084815, 085202, 085455
Recalling Firm/
Manufacturer		 Medacta Usa Inc
4725 Calle Quetzal Ste B
Camarillo, California 93012-8429
For Additional Information Contact Adam Gross
805-437-7085
Reason for
Recall		 The tip of the Quadra Trial Broach size 0, broke during a surgery.
Action Medacta sent a Urgent Safety Notification letter dated December 13, 2012 to all affected customers. The letter identified the recalled product, problem and actions to be taken. Customers were instructed to check inventory for affected product and contact QA@medacta.us.com for an RMA# to return items to Medacta USA. A new version of the recalled product will be provided to all affected customers. For questions call 805-437-7085 x26.
Quantity in Commerce 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
 
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