FDAFDA · Food and drugs·Recall number Z-0564-2016
Radiographic Transparency for Certain and External Connection Tapered Implants. Images that assist with measurements for dental implants.
Published January 6, 2016 · Recall initiated: November 16, 2015
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
Images contained within radiographic transparency ART 1036 are undersized.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Biomet 3i, LLC
- Distributor
- Worldwide Distribution - US Distribution including Puerto Rico., and to the states of : CA, CO, FL, IL, MA, MI, MO, NY, OH, SC, TX, VA, WI, WV and Hawaii., and to the countries of : Australia, Germany, France, Greece, Northern Mariana Islands, Taiwan and Uruguay.
- Lot
- Model Number: ART 1036, Rev. C 03/13; Purchase Order # 184427.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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