| | Class 2 Recall
Dental implant |  |
| Date Posted |
November 16, 2012 |
| Recall Number |
Z-0297-2013 |
| Product |
Product is Full OSSEOTITE 2 Tapered Certain Implant, Model Number XIFNT413, and size 4 x 13 mm. The product is sterile.
Product provides a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed or immediate loading or with a terminal or intermediary abutment for fixed or removable bridgework and to retain over dentures. |
| Code Information |
Model Number XIFNT413, Lot # 2012040462
|
Recalling Firm/
Manufacturer |
Biomet 3i, LLC
4555 Riverside Dr
Palm Beach Gardens, Florida 33410-4200 |
| For Additional Information Contact |
Mark Mashburn
800-342-5454
|
Reason for
Recall |
Biomet 3i recalled Full OSSEOTITE 2 Tapered Certain Implant and Full OSSEOTITE Parallel Walled Certain Implant due to a manufacturing condition where the depth of the implant's internal hex is too shallow. This condition may prevent the driver or abutment from fully engaging in the implant.
|
| Action |
Biomet 3i sent an "URGENT: MEDICAL DEVICE RECALL" letter dated September 28, 2012. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at 1-800-342-5454 for questions regarding this notice. |
| Quantity in Commerce |
191 devices |
| Distribution |
Worldwide Distribution-USA (nationwide) including the states of VA, SC, HI, LA, OH, FL, IL, NJ, NC, CA, CT, MI, TN, AK, NH, NY, MA, GA, PA, and KY and the countries of United Kingdom, Spain, Germany, Canada, Japan, Singapore, Taiwan, Israel, Poland, Hong Kong, Ireland, The Netherlands, Austria, and France. |
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