FDA Device recall Z-0791-2013
Medacta Quadra Trial Broach size 0 part # 01.10.10.045, for use with the Medacta Total Hip Prosthesis System
- FDA Device
- Class II
- terminated
- Published 2013-02-13
On 2013-02-13 the FDA classified a Class II recall of Medacta Quadra Trial Broach size 0 part # 01.10.10.045, for use with the Medacta Total Hip Prosthesis System by Medacta Usa, citing the tip of the Quadra Trial Broach size 0, broke during a surgery.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0791-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-12-17 |
| Published | 2013-02-13 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Medacta Usa |
| Distribution | US |
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.
Reason
The tip of the Quadra Trial Broach size 0, broke during a surgery.
Identifiers
| code_info | Lot/Unit Codes: 075023, 075064, 084000, 084001, 084326, 084743, 084815, 085202, 085455 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0791-2013%22
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