FDAFDA · Food and drugs·Recall number Z-0863-2017
BIOMET 3i LOW PROFILE ABUTMENT TITANIUM RETAINING SCREW 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 # LPCTSH Lots # 2016021930, 2016022074, 2016031247, 2016031248, 2016040024, 2016040025, 2016040064, 2016040898, 2016041632, 2016041635, 2016042030, and 2016042036
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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