Jjgc Industria E Comercio De Materials Dentarios Sa Av Juscelino Kubitschek De Oliveira Curitiba Brazil Neodent Tapered Guided Surgery Drill, Article No. 103.436. UDI 07899878030041. The device is a dental burr. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Neodent Tapered Guided Surgery Drill, Article No. 103.436. UDI 07899878030041. The device is a dental burr.
Brand
Jjgc Industria E Comercio De Materials Dentarios Sa Av Juscelino Kubitschek De Oliveira Curitiba Brazil
Lot Codes / Batch Numbers
Lot WH723
Products Sold
Lot WH723
Jjgc Industria E Comercio De Materials Dentarios Sa Av Juscelino Kubitschek De Oliveira Curitiba Brazil is recalling Neodent Tapered Guided Surgery Drill, Article No. 103.436. UDI 07899878030041. The device is a denta due to The laser engraving of the product incorrectly identifies the 4.3 Tapered Guided Surgery Drill as the "4.3+ Tapered Guided Surgery Drill".. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The laser engraving of the product incorrectly identifies the 4.3 Tapered Guided Surgery Drill as the "4.3+ Tapered Guided Surgery Drill".
Recommended Action
Per FDA guidance
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"
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, IN, PA
Page updated: Jan 10, 2026