Recall Z-1409-2015— Biomet 3i, LLC
Class II · Terminated
Class II FDA medical device recall by Biomet 3i, LLC, initiated 2014-11-07, terminated 2015-05-22. It names one FDA 510(k) clearance: K122300. Product: 3i T3 Non-Platform Switched Tapered Implant Rx Only; 3.25 x 8.5 - 15.0 mm Dental Implants.. Reason: Endosseous Dental Implants in contact with a residual machine fluid caused the implants to be discolored..
- Recalling firm
- Biomet 3i, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-11-07
- Terminated
- 2015-05-22
- Firm location
- Palm Beach Gardens, FL, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
3i T3 Non-Platform Switched Tapered Implant Rx Only; 3.25 x 8.5 - 15.0 mm Dental Implants.
Reason for recall
Endosseous Dental Implants in contact with a residual machine fluid caused the implants to be discolored.
Data sourced from openFDA. This site is unofficial and independent of the FDA.