PlainRecalls
FDA Devices Moderate Class II Terminated

Radiographic Transparency for Certain and External Connection Tapered Implants. Images that assist with measurements for dental implants.

Reported: January 6, 2016 Initiated: November 16, 2015 #Z-0564-2016

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.

Details

Recalling Firm
Biomet 3i, LLC
Units Affected
686
Distribution
Worldwide Distribution - US Distribution including Puerto Rico., and to the states of : CA, CO, FL, IL, MA, MI, MO, NY, OH, SC, TX, VA, WI, WV and Hawaii., and to the countries of : Australia, Germany, France, Greece, Northern Mariana Islands, Taiwan and Uruguay.
Location
Palm Beach Gardens, FL

Frequently Asked Questions

What product was recalled?
Radiographic Transparency for Certain and External Connection Tapered Implants. Images that assist with measurements for dental implants.. Recalled by Biomet 3i, LLC. Units affected: 686.
Why was this product recalled?
Images contained within radiographic transparency ART 1036 are undersized.
Which agency issued this recall?
This recall was issued by the FDA Devices on January 6, 2016. Severity: Moderate. Recall number: Z-0564-2016.