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Nobel Biocare Usa Llc recalls Replace Select Tapered TiU NP 3.5x11.5mm, Article No. 36105 Replace Select Tapered implants are root-form endosseous im
Recalled July 27, 2016 · FDA recall Z-2237-2016 · Nobel Biocare Usa
Hazard
Incorrect top label on an implant package. · FDA Class II
Units
53 units total (33 units in US)
Sold at
Worldwide Distribution - US including OR, OH, NY and Internationally to Taiwan and Brazil Non US: Taiwan, SC
Description
Incorrect top label on an implant package.
Product
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.
Manufacturer(s)
Nobel Biocare Usa Llc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →