BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 3MM(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
Reported: December 28, 2016 Initiated: September 14, 2016 #Z-0842-2017
Product Description
BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 3MM(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
Reason for Recall
A limited number of product pouches may not have been sealed during packaging.
Details
- Recalling Firm
- Biomet 3i, LLC
- Units Affected
- 46
- Distribution
- Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden
- Location
- Palm Beach Gardens, FL
Frequently Asked Questions
What product was recalled? ▼
BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 3MM(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. Recalled by Biomet 3i, LLC. Units affected: 46.
Why was this product recalled? ▼
A limited number of product pouches may not have been sealed during packaging.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 28, 2016. Severity: Moderate. Recall number: Z-0842-2017.
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