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Recall Observatory FDA recall evidence

Device product

OSSEOTITE Certain 2 Implant Rx only; 3.25 x 8.5 - 18 mm. Dental Implants.

Z-1411-2015

November 07, 2014

Class II

Product summary

Firm
Biomet 3i, LLC
Event
Event 70628
Status
Terminated
Classification
Class II
Quantity
620 implants in total
Official record key
device-enforcement:Z-1411-2015

Official wording

Reason: Endosseous Dental Implants in contact with a residual machine fluid caused the implants to be discolored.

Code information: Implant PN # XIFOSM311 Lot # 2014051368 Exp date 12/03/2018

Distribution pattern: Worldwide Distribution-US (nationwide) including the states of AL, AZ, CA, CO, CT, DE, FL, GA, IL, KY, LA, MA, MD, MI, NC, NH, NJ, NY, OH, OR, PA, SC, TN, TX, VA, WA and HI and the countries of Austria, Australia, Canada, France, Germany, Italy, Japan, Netherlands, New Zealand, Portugal, Spain, Turkey, Taiwan, and United Kingdom.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Endosseous Dental Implants in contact with a residual machine fluid caused the implants to be discolored.