Recall Z-2426-2016 ยท DZE Implant, Endosseous, Root-Form
Biomet 3i, LLC
O-Ring Abutment 4.1mm(D) x 6mm(H) Item: OSO60 Dental implants
| Date | Aug 12, 2016 (initiated Nov 25, 2015) |
| Status | Terminated |
| Reason | Pouches may not have been sealed during packing. |
| Root cause | Packaging |
| Action | Biomet sent an Urgent Device Recall Notice to all affected consignees the week of November 30, 2015, communicating the issue and customer responsibilities. International consignees were notified via traceable courier or email week of November 30, 2015. Customers were instructed to return affected product by calling BIOMET at 1-800-342-5454 to obtain a RMA number to return products. Customers were also asked to complete the Business Reply Form and fax to 561-514-6316. For questions regarding this recall call 561-776-6700. |
| Quantity | 1,648,273 (all products subject to these recall) |
| Distribution | Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, German |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K891613 | OVERDENTURE ATTACHMENT Implant Innovations International, Inc., Oct 10, 1989 |