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Instradent USA, Inc. recalls NEODENT CM Intraoral Scanbody, Article Number: 108.139
Recalled April 26, 2017 · FDA recall Z-1831-2017 · Instradent USA
Hazard
During internal testing, Neodent determined that the body diameter (3.8mm) of the Neodent 108.139 CM Exact Intraoral Scan body is not compatible with the platform diameter of CM Implants when the implant is intraosseoussly (subcrestally) positioned. · FDA Class II
Units
170 pieces
Sold at
Distributed to the states of: NJ, TX, NV, CA, PA, AZ, and IL.
Description
During internal testing, Neodent determined that the body diameter (3.8mm) of the Neodent 108.139 CM Exact Intraoral Scan body is not compatible with the platform diameter of CM Implants when the implant is intraosseoussly (subcrestally) positioned.
Product
NEODENT CM Intraoral Scanbody, Article Number: 108.139
Manufacturer(s)
Instradent USA, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →