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U.S. Department of Health and Human Services

Class 2 Device Recall Quadra Trial Broach size 0

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  Class 2 Device Recall Quadra Trial Broach size 0 see related information
Date Initiated by Firm December 17, 2012
Date Posted February 07, 2013
Recall Status1 Terminated 3 on February 07, 2013
Recall Number Z-0791-2013
Recall Event ID 64160
510(K)Number K072857  K082792  K083558  K093944  K103189  
Product Classification Quadra Trial Broach size 0 - Product Code MEH
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 CA 93012-8429
For Additional Information Contact Adam Gross
805-437-7085
Manufacturer Reason
for Recall		 The tip of the Quadra Trial Broach size 0, broke during a surgery.
FDA Determined
Cause 2		 Device Design
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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MEH and Original Applicant = MEDACTA INTERNATIONAL, SA
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