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Class 2 Device Recall SINGLES Carbides Dental Burs |
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Date Initiated by Firm |
November 07, 2018 |
Create Date |
November 19, 2019 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-0493-2020 |
Recall Event ID |
83776 |
Product Classification |
Bur, dental - Product Code EJL
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Product |
Singles 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+ |
Recalling Firm/ Manufacturer |
Hager & Meisinger Gmbh Ronsdorferstrasse 22 Dusseldorf Germany
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For Additional Information Contact |
Customer Service 303-2685400
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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.
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FDA Determined Cause 2 |
Employee error |
Action |
On 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 Commerce |
2500 burs |
Distribution |
US: NV, PA, FL, SC, IA, NC- |
Total Product Life Cycle |
TPLC Device Report
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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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