Neodent Tapered Guided Surgery Drill, Article No. 103.436. UDI 07899878030041. The device is a de...
FDA Recall #Z-0924-2020 — Class II — December 23, 2019
Product Description
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".
Recalling Firm
Jjgc Industria E Comercio De Materials Dentarios Sa — Curitiba, N/A
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
2
Distribution
Distributed to consignees in CA and PA.
Code Information
Lot WH723
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated