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U.S. Department of Health and Human Services

Class 2 Device Recall SINGLES Carbides Dental Burs

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 Class 2 Device Recall SINGLES Carbides Dental Burssee related information
Date Initiated by FirmNovember 07, 2018
Create DateNovember 19, 2019
Recall Status1 Open3, Classified
Recall NumberZ-0493-2020
Recall Event ID 83776
Product Classification Bur, dental - Product Code EJL
ProductSingles carbides by Meisinger, US-No: 245, Sterile R, cylinder round end; US-No 245; Reference: HMUN245-009; Shank: FG/314; Head Size 1/10mm: 009,Head Length/mm:
Code Information Lot #R23891 UDI: +E0HM26UN2453140099/$$8250523R23891+
FEI Number 8010516
Recalling Firm/
Manufacturer		 Hager & Meisinger Gmbh
Ronsdorferstrasse 22
Dusseldorf Germany
For Additional Information ContactCustomer Service
303-2685400
Manufacturer Reason
for Recall		Incorrect packaging; There is a potential that a 1.0 mm carbide blade was packaged in a 0.9 mm carbide blade packaging.
FDA Determined
Cause 2		Employee error
ActionOn 10/29/2018, a medical device removal notice was mailed to the customers instructing them to do the following: 1. check your inventory for burs from the affected batch . Please return any affected instruments. You will receive a swift replacement. 2. If you have further distributed this product, please identify your customers in the response form attached . 3. Please complete the reposne orm and sent it bat to the firm at +1 (303268-5407 or by e-mail at dsanmiguel@meisingerusa.com 4. For further questions, our customer service is available at +1 (303)268-5407
Quantity in Commerce2500 burs
DistributionUS: NV, PA, FL, SC, IA, NC-
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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