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.
FDA Recall Z-0791-2013 · Posted 2013-02-07
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Recalling FirmMedacta Usa Inc
Recall StatusTerminated
Product CodeMEH
Date Initiated2012-12-17
Date Terminated2013-02-07
Product Quantity26 pieces U.S.A. (226 pieces Worldwide)
Reason for Recall
The tip of the Quadra Trial Broach size 0, broke during a surgery.
Firm 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 [email protected] 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.
Root Cause
Device Design
Distribution Pattern
US Nationwide Distribution including the states of Arizona, California, Idaho, Illinois, North Carolina, Ohio, Utah, Washington and US Virgin Islands
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
K103189MEDACTA TOTAL HIP PROSTHESIS SYSTEM - AMISTEM C & QUADRA C SHORT NECKMedacta International S.A. · 2010-12-20K093944MEDACTA TOTAL HIP PROTHESIS SYSTEM-AMISTEN H , QUADRA H, QUADRA SMedacta International S.A. · 2010-01-21K083558MEDACTA TOTAL HIP PROSTHESIS SYSTEM - QUADRA CMedacta International S.A. · 2009-03-06K082792MEDACTA TOTAL HIP PROSTHESIS SYSTEM - QUADRA H AND R FEMORAL STEMSMedacta International S.A. · 2008-12-29K072857TOTAL HIP PROSTHESIS SYSTEM QUADRA S + COCRMO FEMORAL BALL HEAD + APRICOTMedacta International S.A. · 2008-02-04
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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