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U.S. Department of Health and Human Services

Class 2 Device Recall Neodent Tapered Guided Surgery Drill

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 Class 2 Device Recall Neodent Tapered Guided Surgery Drillsee related information
Date Initiated by FirmDecember 23, 2019
Date PostedJanuary 30, 2020
Recall Status1 Terminated 3 on June 01, 2021
Recall NumberZ-0924-2020
Recall Event ID 84709
Product Classification Bur, dental - Product Code EJL
ProductNeodent Tapered Guided Surgery Drill, Article No. 103.436. UDI 07899878030041. The device is a dental burr.
Code Information Lot WH723
Recalling Firm/
Manufacturer		 Jjgc Industria E Comercio De Materials Dentarios Sa
Av Juscelino Kubitschek De Oliveira
Curitiba Brazil
For Additional Information ContactCustomer Service
858-7503066
Manufacturer 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 Determined
Cause 2		Under Investigation by firm
ActionCustomers 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 Commerce2
DistributionDistributed to consignees in CA and PA.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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