BIOMET 3i Endosseous Dental Implant.
Reported: April 23, 2014 Initiated: August 29, 2013 #Z-1458-2014
Product Description
BIOMET 3i Endosseous Dental Implant.
Reason for Recall
Due to residual machining fluid identified by discoloration (darker in appearance) on the external dental implant surface.
Details
- Recalling Firm
- Biomet 3i, LLC
- Units Affected
- 34,744
- Distribution
- Worldwide Distribution - USA and countries of United Arab Emirates, Argentina, Austria, Australia, Belgium, Brazil, Canada, Switzerland, Chile, Colombia, Costa Rica, Germany, Dominican Republic, Spain, France, Great Britain (UK), Greece, Hong Kong, Ireland, Israel, India, Italy, Japan, Korea (South), Lebanon, Liechtenstein, Lithuania, Mexico, Netherlands, Poland, Portugal, Paraguay, Saudi Arabia, Sweden, Singapore, Turkey, Taiwan, Uruguay, Vietnam and South Africa.
- Location
- Palm Beach Gardens, FL
Frequently Asked Questions
What product was recalled? ▼
BIOMET 3i Endosseous Dental Implant.. Recalled by Biomet 3i, LLC. Units affected: 34,744.
Why was this product recalled? ▼
Due to residual machining fluid identified by discoloration (darker in appearance) on the external dental implant surface.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 23, 2014. Severity: Moderate. Recall number: Z-1458-2014.
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