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Recall Observatory FDA recall evidence

Device product

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

Z-0564-2016

November 16, 2015

Class II

Product summary

Firm
Biomet 3i, LLC
Event
Event 72658
Status
Terminated
Classification
Class II
Quantity
686
Official record key
device-enforcement:Z-0564-2016

Official wording

Reason: Images contained within radiographic transparency ART 1036 are undersized.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Images contained within radiographic transparency ART 1036 are undersized.