Recall Z-0564-2016 ยท NDP Accessories, Implant, Dental, Endosseous
Biomet 3i, LLC
Radiographic Transparency for Certain and External Connection Tapered Implants. Images that assist with measurements for dental implants.
| Date | Dec 31, 2015 (initiated Nov 16, 2015) |
| Status | Terminated |
| Reason | Images contained within radiographic transparency ART 1036 are undersized. |
| Root cause | Software design (manufacturing process) |
| Action | BIOMET3i sent an" Urgent Medical Device Recall letter " dated November, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Responsibilities: 1. Please review this notice and check your inventory for the affected item by comparing any on-hand ART 1036 Transparencies to a standard 8.5" x 11" sheet of paper. The non-conforming ART 1036 is approximately 7.8" x 10.2". 2. Immediately quarantine and remove all affected items from service. 3. Complete the attached Business Reply Form and either: a. fax it to 561-5 |
| Quantity | 686 |
| Distribution | Worldwide Distribution - US Distribution including Puerto Rico., and to the states of : CA, CO, FL, IL, MA, MI, MO, NY, OH, SC, TX, VA, WI, WV and Hawaii., and to the countries of : Australia, Germany, France, Greece, Northern Mariana Islands, Taiwan and Uruguay. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.