Recall Z-0791-2013— Medacta Usa Inc
Class II · Terminated
Class II FDA medical device recall by Medacta Usa Inc, initiated 2012-12-17, terminated 2013-02-07. It names 5 FDA 510(k) clearances: K103189, K093944, K083558 and 2 more. 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..
- Recalling firm
- Medacta Usa Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-12-17
- Terminated
- 2013-02-07
- Firm location
- Camarillo, CA, United States
510(k) clearances named in this recall
5 on FDA's record- K103189 — MEDACTA TOTAL HIP PROSTHESIS SYSTEM - AMISTEM C & QUADRA C SHORT NECK
- K093944 — MEDACTA TOTAL HIP PROTHESIS SYSTEM-AMISTEN H , QUADRA H, QUADRA S
- K083558 — MEDACTA TOTAL HIP PROSTHESIS SYSTEM - QUADRA C
- K082792 — MEDACTA TOTAL HIP PROSTHESIS SYSTEM - QUADRA H AND R FEMORAL STEMS
- K072857 — TOTAL HIP PROSTHESIS SYSTEM QUADRA S + COCRMO FEMORAL BALL HEAD + APRICOT
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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 for recall
The tip of the Quadra Trial Broach size 0, broke during a surgery.
Data sourced from openFDA. This site is unofficial and independent of the FDA.