Recall Z-2237-2016 ยท DZE Implant, Endosseous, Root-Form
Nobel Biocare Usa Llc
Replace Select Tapered TiU NP 3.5x11.5mm, Article No. 36105 Replace Select Tapered implants are root-form endosseous implants intended to be surgically placed in the bone of the upper and lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore patient esthetics and chewing function.
| Date | Jun 22, 2016 |
| Status | Terminated |
| Reason | Incorrect top label on an implant package. |
| Root cause | Labeling False and Misleading |
| Action | Nobel Biocare sent a customer notification letter dated June 23, 2016 to all affected customers to inform them that Nobel Biocare has detected that the lot#13030677 of Replace Select Tapered TiU NP 3.5 x 11.5 mm (product#36105) carries an incorrect top label. The letter informs the customers that the incorrect top label states "Replace NP 3.5 x 11.5 CC" (ie. Conical Connection). The product, Replace Select Tapered TiU NP 3.5 x 11.5 mm, has a Tri-lobe connection. Customers were instructed to complete the attached Quality Message Acknowledgement form. Customer with questions were instructed t |
| Quantity | 53 units total (33 units in US) |
| Distribution | Worldwide Distribution - US including OR, OH, NY and Internationally to Taiwan and Brazil Non US: Taiwan, SC |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.