Recall Z-1419-2015 ยท DZE Implant, Endosseous, Root-Form
Nobel Biocare Usa Llc
NOBELREPLACE Tapered Groovy RP 4.3x8mm, Article No. 32215. Nobel Biocare's Dental Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare's Dental Implants are indicated for single or multi
| Date | Apr 13, 2015 (initiated Mar 9, 2015) |
| Status | Terminated |
| Reason | A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads. |
| Root cause | Nonconforming Material/Component |
| Action | Nobel Biocare sent an Important - Field Correction letter dated March 6, 2015, to all affected customers and another recall letter dated dated March 10, 2015, to all affected customers to inform them that Nobel Biocare Quality Management Systems observed an issue with a material used in the packaging of their implants. The firm's internal analysis has confirmed that this material is not according to their standards. The letters provide the problems identified and the actions to be taken. Customers were instructed to return the affected product(s) not yet used to Nobel Biocare to receive a r |
| Quantity | 138 units |
| Distribution | Worldwide Distribution - US (nationwide) and Internationally to Austria, Australia, Belgium, Bulgaria, Canada, Switzerland, Czech Republic, Germany, Denmark, Estonia, Spain, Finland, France, United Kingdom, Greece, Croatia, Hungary, Ireland, Italy, Lithuania, Luxembourg, Mexico, Netherlands, Norway, |
| FDA record | Open on fda.gov |