Reported Feb 13, 2013 · Terminated

Medacta Quadra Trial Broach size 0 part # 01.10.10.045, for use with the Medacta Total Hip Prosthesis System. Product…

Medacta USA Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Medacta Usa Inc · 4725 Calle Quetzal Ste B · Camarillo, CA · 93012-8429

Is this the product you have?

  • 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.
Lot codes and dates
  • Lot/Unit Codes
    • 075023
    • 075064
    • 084000
    • 084001
    • 084326
    • 084743
    • 084815
    • 085202
    • 085455
Amount recalled
26 pieces U.S.A. (226 pieces Worldwide)

Where it was sold

Why it was recalled

The tip of the Quadra Trial Broach size 0, broke during a surgery.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Feb 7, 2013 · Data as of Sep 19, 6:14 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.