CLASS II Device recall · Reported 13 Feb 2013 · FDA Enforcement Report
Medacta Quadra Trial Broach size 0 part # recalled
Medacta Usa is recalling Medacta Quadra Trial Broach size 0 part # 01.10.10.045, for use with the Medacta Total, distributed nationwide in the US. The recall was initiated on 17 Dec 2012 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0791-2013
- FDA event ID
- 64160
- Recalling firm
- Medacta Usa, Camarillo, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Dec 2012
- FDA classified
- 6 Feb 2013
- Reported
- 13 Feb 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 17 Dec 2012 | Recall initiated by company | |
| 6 Feb 2013 | Classified by FDA | +51 days |
| 13 Feb 2013 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The tip of the Quadra Trial Broach size 0, broke during a surgery.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide Distribution including the states of Arizona, California, Idaho, Illinois, North Carolina, Ohio, Utah, Washington and US Virgin Islands
Nationwide ArizonaCaliforniaIdahoIllinoisNorth CarolinaOhioUtahWashington
Questions about this recall
Why was it recalled?
The tip of the Quadra Trial Broach size 0, broke during a surgery.
Which lots are affected?
Lot/Unit Codes: 075023, 075064, 084000, 084001, 084326, 084743, 084815, 085202, 085455
Where was it sold?
US Nationwide Distribution including the states of Arizona, California, Idaho, Illinois, North Carolina, Ohio, Utah, Washington and US Virgin Islands
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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