BIOMET 3i, PROVIDE IMPRESSION COPING KITS, Catalog # PRK484, PRK485, PRK654, and PRK655 BIOMET 3i Restorative Products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible. Provisional Abutments are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. They are intended for use to support a prosthesis in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non-occlusal loading of provisional restorations.
Recall
- Recall Number
- Z-0594-2016
- Event Number
- 72446
- Firm
- Biomet 3i, LLC
- FEI Number
- 1038806
- Product Code
- NDP
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- September 21, 2015
- Posted
- January 6, 2016
- Terminated
- October 12, 2016
- Address
- 4555 Riverside Dr, Palm Beach Gardens, FL, 33410-4200
Description
BIOMET 3i, PROVIDE IMPRESSION COPING KITS, Catalog # PRK484, PRK485, PRK654, and PRK655 BIOMET 3i Restorative Products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible. Provisional Abutments are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. They are intended for use to support a prosthesis in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non-occlusal loading of provisional restorations.
Inadequate biocompatibility testing.
The firm, Biomet 3i, sent an "URGENT DEVICE RECALL NOTICE" letter dated September 16, 2015 to both Domestic and Foreign Customers via traceable courier. The letter described the product, problem and actions to be taken. The customers were instructed to review the notice and check your inventory for the affected units; immediately quarantine and remove all affected products from service; if you have product to return, call Biomet 3i Complaints Department at 1-800-443-8166 or 1-561-776-6700 to obtain a CMP# and return affected product to Biomet 3i Returns, 4555 Riverside Dr., Palm Beach Gardens, FL 34410; complete and return the attached Business Reply Form via fax to: +1-561-514-6316 or email to: [email protected], and maintain a copy of the notice for your records. For assistance or any other questions that you may have, please contact Biomet 3i Complaints Department at 1-800-443-8166 or 1-561-776-6700. The Complaints Department is available 8:00am to 6:00pm (Eastern), Monday through Friday.
Worldwide Distribution: US (nationwide) and countries of: Canada, Argentina, Austria, Australia, Brazil, Chile, China, Colombia, Costa Rica, Germany, Dominican Republic, Spain, France, Great Britain, Hong Kong, Ireland, Israel, India, Korea, Kuwait, Lithuania, Mexico, Netherlands, Portugal, Saudi Arabia, Sweden, Singapore, Taiwan, Venezuela, and South Africa.
30,111 devices.