Recall Z-0564-2016— Biomet 3i, LLC
Class II · Terminated
Class II FDA medical device recall by Biomet 3i, LLC, initiated 2015-11-16, terminated 2016-12-14. FDA's recall record names no specific 510(k) clearance for this event. Product: Radiographic Transparency for Certain and External Connection Tapered Implants. Images that assist with measurements for dental implants.. Reason: Images contained within radiographic transparency ART 1036 are undersized..
- Recalling firm
- Biomet 3i, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-11-16
- Terminated
- 2016-12-14
- Firm location
- Palm Beach Gardens, FL, United States
Product description
Radiographic Transparency for Certain and External Connection Tapered Implants. Images that assist with measurements for dental implants.
Reason for recall
Images contained within radiographic transparency ART 1036 are undersized.
Data sourced from openFDA. This site is unofficial and independent of the FDA.