Device product

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

Z-0924-2020

December 23, 2019

Class II

Product summary

Firm: Jjgc Industria E Comercio De Materials Dentarios Sa
Event: Event 84709
Status: Terminated
Classification: Class II
Quantity: 2
Official record key: device-enforcement:Z-0924-2020

Official wording

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

Code information: Lot WH723

Distribution pattern: Distributed to consignees in CA and PA.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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