Biomet 3i, LLC: Medical Device Recall in 2016 - (Recall #: Z-0564-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 16, 2015

Date Posted: January 6, 2016

Recall Number: Z-0564-2016

Event ID: 72658

Reason for Recall:

Images contained within radiographic transparency ART 1036 are undersized.

Status: Terminated

Product Quantity: 686

Code Information:

Model Number: ART 1036, Rev. C 03/13; Purchase Order # 184427.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated