Z-0924-2020Class II

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

Name: Z-0924-2020 Neodent Tapered Guided Surgery Drill, Article No. 103.436. UDI 07899878030041. The device is a dental burr
Creator: Jjgc Industria E Comercio De Materials Dentarios Sa
Published: 2019-12-23
License: https://open.fda.gov/license/

JJGC Industria e Comercio de Materiais Dentarios SA / initiated 2019-12-23 / Terminated

FDA source

Jjgc Industria E Comercio De Materials Dentarios Sa began a recall of Neodent Tapered Guided Surgery Drill, Article No. 103.436. UDI 07899878030041. The device is a dental burr on 2019-12-23. FDA classified it as Class II and gives the reason as "The laser engraving of the product incorrectly identifies the 4.3 Tapered Guided Surgery Drill as the "4.3+ Tapered Guided Surgery Drill"". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0924-2020
Classification: Class II
Status: Terminated
Initiated: 2019-12-23
Posted: 2020-01-30
Terminated: 2021-06-01
Recalling firm: JJGC Industria e Comercio de Materiais Dentarios SA
Product: Neodent Tapered Guided Surgery Drill, Article No. 103.436. UDI 07899878030041. The device is a dental burr.
Product code: EJL Bur, Dental
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".
FDA root cause: Under Investigation by firm
Action: Customers were notified of the recall on 12/23/2019 via telephone and email. Customers were instructed to do the following: - If the clinician has already used the drill for osteotomy and successfully concluded the installation of the implant, additional patient follow-up not required. The implant will behave as normally expected. - Identify and segregate the affected units, opened or unopened, in your stock. - If the product is still in your inventory, return it to the attention of "Action 0002/2019 Product Removal" for credit as indicated on ANNEX 1: Customer Confirmation Form. - If the product cannot be located, indicate this on the Customer Confirmation Form. - For either case, complete and return the Customer Confirmation Form to "Action 0002/2019 Product Removal"
Quantity in commerce: 2
Distribution: Distributed to consignees in CA and PA.
Product codes and lots: Lot WH723

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0924-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0924-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-01-31

Product code EJL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)