Medacta Quadra Trial Broach size 0 part # 01.10.10.045, for use with the Medacta Total Hip Prosthesis System. Product Us
FDA device recall Z-0791-2013 · posted 2013-02-07 · Terminated
Recall details
- Recalling firm
- Medacta Usa Inc
- Reason for recall
- The tip of the Quadra Trial Broach size 0, broke during a surgery.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- MEH
- Quantity affected
- 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
- Date initiated
- 2012-12-17
- Date posted
- 2013-02-07
- Date terminated
- 2013-02-07
- Location
- Camarillo, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MEDACTA TOTAL HIP PROSTHESIS SYSTEM - AMISTEM C & QUADRA C SHORT NECK (K103189) | Medacta International S.A. | 2010-12-20 |
| MEDACTA TOTAL HIP PROTHESIS SYSTEM-AMISTEN H , QUADRA H, QUADRA S (K093944) | Medacta International S.A. | 2010-01-21 |
| MEDACTA TOTAL HIP PROSTHESIS SYSTEM - QUADRA C (K083558) | Medacta International S.A. | 2009-03-06 |
| MEDACTA TOTAL HIP PROSTHESIS SYSTEM - QUADRA H AND R FEMORAL STEMS (K082792) | Medacta International S.A. | 2008-12-29 |
| TOTAL HIP PROSTHESIS SYSTEM QUADRA S + COCRMO FEMORAL BALL HEAD + APRICOT (K072857) | Medacta International S.A. | 2008-02-04 |