Recall Z-1458-2014— Biomet 3i, LLC
Class II · Terminated
Class II FDA medical device recall by Biomet 3i, LLC, initiated 2013-08-29, terminated 2014-10-17. FDA's recall record names no specific 510(k) clearance for this event. Product: BIOMET 3i Endosseous Dental Implant.. Reason: Due to residual machining fluid identified by discoloration (darker in appearance) on the external dental implant surface..
- Recalling firm
- Biomet 3i, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-08-29
- Terminated
- 2014-10-17
- Firm location
- Palm Beach Gardens, FL, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.