Recall Z-0594-2016 ยท NDP Accessories, Implant, Dental, Endosseous
Biomet 3i, LLC
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
| Date | Jan 6, 2016 (initiated Sep 21, 2015) |
| Status | Terminated |
| Reason | Inadequate biocompatibility testing. |
| Root cause | Process control |
| Action | 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, |
| Quantity | 30,111 devices. |
| Distribution | 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 Ar |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.