OSSEOTITE Certain 2 Implant Rx only; 3.25 x 8.5 - 18 mm. Dental Implants.
FDA Recall Z-1411-2015 · 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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.