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Terminated

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

FDA Recall Z-0924-2020 · Posted 2020-01-30

Recalling FirmJjgc Industria E Comercio De Materials Dentarios Sa
Recall StatusTerminated
Product CodeEJL
Date Initiated2019-12-23
Date Terminated2021-06-01
Product Quantity2

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".

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"

Root Cause

Under Investigation by firm

Distribution Pattern

Distributed to consignees in CA and PA.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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