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.
Recall
- Recall Number
- Z-2237-2016
- Event Number
- 74486
- Firm
- Nobel Biocare Usa Llc
- FEI Number
- 1000125598
- Product Code
- DZE
- Status
- Terminated
- Root Cause
- Labeling False and Misleading
- Initiated
- June 22, 2016
- Terminated
- September 6, 2016
- Address
- 22715/22725 Savi Ranch Pkwy, Yorba Linda, CA, 92887
Description
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.
Incorrect top label on an implant package.
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 to contact customer service at 714-282-4808.
Worldwide Distribution - US including OR, OH, NY and Internationally to Taiwan and Brazil Non US: Taiwan, SC
53 units total (33 units in US)