Recall Z-2838-2011 ยท NSP Restoration, Porcelain
Biomet 3i, LLC
"***3i Incise Custom-Made Label. QP157 Approved 07/09/10*** 3i inc se Custom-made Dental Framework***Biomet 3i 4555 Riverside Drive Palm Beach Gardens, FL 33410 800-342-5454 www.biomet3i.com Please consult instructions for use and recommendation***For Dental Lab use ONLY Non-sterile/For single Use***" Indicated for use in restorative procedure to affix the final prosthesis to the abutment. Coping
| Date | Jul 16, 2011 (initiated Dec 1, 2010) |
| Status | Terminated |
| Reason | On December 1, 2010 Biomet 3i recalled their product Incise Zirconia Coping (CBZR0102). The Coping contains a manufacturing defect. Coping is oversized. All affected direct accounts were notified by letter on December 14, 2010. |
| Root cause | Nonconforming Material/Component |
| Action | Biomet 3i sent an "MEDICAL DEVICE RECALL" letter dated December 14, 2010 to all affected customers. The letter identifies the product, problem, and actions to be taken. The letter instructs customers to complete and fax the Product Recall Response form to 561-514-6316. In addition, a shipping label is enclosed with the letter for returning the affected product. Customers with questions and concerns should contact Biomet 3i recall coordinator at 561-776-6906. |
| Quantity | 16 |
| Distribution | Worldwide Distribution--USA (nationwide) and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.