FDA Medical Device Recalls (openFDA)
Jjgc Industria E Comercio De Materials Dentarios Sa: Neodent Tapered Guided Surgery Drill, Article No. 103.436. UDI 07899878030041. The device is a dental burr.
- Recall number
- Z-0924-2020
- Recalling firm
- Jjgc Industria E Comercio De Materials Dentarios Sa
- Product
- Neodent Tapered Guided Surgery Drill, Article No. 103.436. UDI 07899878030041. The device is a dental burr.
- Status
- Terminated
- Initiated
- 2019-12-23
- Posted
- 2020-01-30
- Terminated
- 2021-06-01
- Reason
- The laser engraving of the product incorrectly identifies the 4.3 Tapered Guided Surgery Drill as the "4.3+ Tapered Guided Surgery Drill".
- 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
- 2
- Distribution
- Distributed to consignees in CA and PA.
- Lot, serial or model codes
- Lot WH723
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- EJL
- Firm FEI
- 3008261720
- Firm city
- Curitiba
- Firm state
- not on file
- Firm country
- Brazil
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28