FDAFDA · Food and drugs·Recall number Z-0202-2015
GMK Intramedullary Extension Rod 100 mm is a rod to obtain correct leg alignment during total knee replacement. Rod to obtain correct leg alignment during total knee replacement.
Published November 19, 2014 · Recall initiated: September 22, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Medacta has registered in its database 3 cases of breakage of the GMK Intramedullary Extension Rod 100 mm, code 02.07.10.0162.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Medacta Usa
- Distributor
- Worldwide Distribution - US including OH and Internationally to Australia, Austria, Belgium, France, Germany, Greece, Italy, Japan, Portugal, South Africa, Spain, and Switzerland.
- Lot
- Model Number: 02.07.10.0162
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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