FDA recall Z-0924-2020

Jjgc Industria E Comercio De Materials Dentarios Sa · Class II · device

Product

Neodent Tapered Guided Surgery Drill, Article No. 103.436. UDI 07899878030041. The device is a dental burr.

Reason for recall

The laser engraving of the product incorrectly identifies the 4.3 Tapered Guided Surgery Drill as the "4.3+ Tapered Guided Surgery Drill".

Distribution

Distributed to consignees in CA and PA.

Key facts

Status
Terminated
Initiation date
2019-12-23
Report date
2020-02-12
Termination date
2021-06-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
Curitiba, N/A, Brazil

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0924-2020