Recall Z-0791-2013 ยท MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Medacta Usa Inc
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.
| Date | Feb 7, 2013 (initiated Dec 17, 2012) |
| Status | Terminated |
| Reason | The tip of the Quadra Trial Broach size 0, broke during a surgery. |
| Root cause | 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 | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072857 | TOTAL HIP PROSTHESIS SYSTEM QUADRA S + COCRMO FEMORAL BALL HEAD + APRICOT Medacta International S.A., Feb 4, 2008 |
| K082792 | MEDACTA TOTAL HIP PROSTHESIS SYSTEM - QUADRA H AND R FEMORAL STEMS Medacta International S.A., Dec 29, 2008 |
| K083558 | MEDACTA TOTAL HIP PROSTHESIS SYSTEM - QUADRA C Medacta International S.A., Mar 6, 2009 |
| K093944 | MEDACTA TOTAL HIP PROTHESIS SYSTEM-AMISTEN H , QUADRA H, QUADRA S Medacta International S.A., Jan 21, 2010 |
| K103189 | MEDACTA TOTAL HIP PROSTHESIS SYSTEM - AMISTEM C & QUADRA C SHORT NECK Medacta International S.A., Dec 20, 2010 |