FDA-Device2016-07-27Class II
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.
Nobel Biocare Usa Llc
Hazard
Incorrect top label on an implant package.
Sold states
Worldwide Distribution - US including OR, OH, NY and Internationally to Taiwan and Brazil Non US: Taiwan, SC
Affected count
53 units total (33 units in US)
Manufactured in
22715/22725 Savi Ranch Pkwy, N/A, Yorba Linda, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2237-2016Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief