FDAFDA · Food and drugs·Recall number Z-1410-2015
OSSEOTITE Tapered Certain Implant Rx Only; 3.25 x 18.5 - 15.0 mm. Dental Implants.
Published April 22, 2015 · Recall initiated: November 7, 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
Endosseous Dental Implants in contact with a residual machine fluid caused the implants to be discolored.
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 (nationwide) including the states of AL, AZ, CA, CO, CT, DE, FL, GA, IL, KY, LA, MA, MD, MI, NC, NH, NJ, NY, OH, OR, PA, SC, TN, TX, VA, WA and HI and the countries of Austria, Australia, Canada, France, Germany, Italy, Japan, Netherlands, New Zealand, Portugal, Spain, Turkey, Taiwan, and United Kingdom.
- Lot
- Implant PN # IFNT3211 Lot # 2014051477 Exp date 12/06/2018
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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