FDAFDA · Food and drugs·Recall number Z-0841-2017
BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 2MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
Published December 28, 2016 · Recall initiated: September 14, 2016
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
A limited number of product pouches may not have been sealed during packaging.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Biomet 3i, LLC
- Distributor
- Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden
- Lot
- Part # ILPC442U Lot # 2015110458, 2015111460, 2015121066, 2016020509, and 2016042047
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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