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Terminated

OSSEOTITE Tapered Certain Implant Rx Only; 3.25 x 18.5 - 15.0 mm. Dental Implants.

FDA Recall Z-1410-2015 · Posted 2015-04-10

Recalling FirmBiomet 3i, LLC
Recall StatusTerminated
Product CodeDZE
Date Initiated2014-11-07
Date Terminated2015-05-22
Product Quantity620 implants in total

Reason for Recall

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

Firm Action

Biomet 3i sent an URGENT MEDICAL DEVICE RECALL NOTICE dated November 7, 3014 to all affected customers. The letter identified the product, problem, and actions to be taken by the customer.

Root Cause

Manufacturing material removal

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K100724OSSEOTITE II MODEL XIFOSSXXXBiomet 3i, Inc. · 2011-04-01

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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