CLASS II Device recall · Reported 14 Nov 2012 · FDA Enforcement Report
Quadra S Offset Broach Handle The offset broach handle recalled
Medacta Usa is recalling Quadra S Offset Broach Handle The offset broach handle is intended to attach to the, distributed in Colorado, Nevada, Texas. The recall was initiated on 13 Oct 2008 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-0267-2013
- FDA event ID
- 53337
- Recalling firm
- Medacta Usa, Camarillo, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Oct 2008
- FDA classified
- 8 Nov 2012
- Reported
- 14 Nov 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 13 Oct 2008 | Recall initiated by company | |
| 8 Nov 2012 | Classified by FDA | +1487 days |
| 14 Nov 2012 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Medacta USA Inc has initiated a recall on the Quadra S Offset Broach Handle because of the potential of the rivet that locks the metallic wire to the lever may become loose during a surgery and make it impossible to lock/unlock the broaches.
Product as listed by the FDA
Quadra S Offset Broach Handle The offset broach handle is intended to attach to the broaches of different sizes as the surgeon broaches the femoral bone in preparation for the implantation of the femoral stem.
Where it was distributed
Worldwide Distribution -- US including the states of Texas, Nevada and Colorado., and the country of Belgium.
Questions about this recall
Why was it recalled?
Medacta USA Inc has initiated a recall on the Quadra S Offset Broach Handle because of the potential of the rivet that locks the metallic wire to the lever may become loose during a surgery and make it impossible to lock/unlock the broaches.
Which lots are affected?
Ref: 01.10.10.122 (Lot # 085119), Ref: 01.10.10.123 (Lot # 085120), Ref: 01.10.10.124 (Lot # 085244), Ref: 01.10.10.125 (Lot # 085243)
Where was it sold?
Worldwide Distribution -- US including the states of Texas, Nevada and Colorado., and the country of Belgium.
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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