FDAFDA · Food and drugs·Recall number Z-2594-2014
BIOMET 3i Certain Bellatek Encode Healing Abutment Biomet 3i Healing abutments are temporary abutments indicated for use in maintaining the soft tissue opening throughout the healing process prior to dental restoration.
Published September 17, 2014 · Recall initiated: June 25, 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
Identifiers on the label are correct but the label has the incorrect color coding.
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
- US Distribution to NH and TX.
- Lot
- Model Number IEHA458, Lot number: 1167545.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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