Recall Z-0493-2020 ยท EJL Bur, Dental
Hager & Meisinger Gmbh
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:
| Date | Nov 7, 2018 |
| Status | Open, Classified |
| Reason | Incorrect packaging; There is a potential that a 1.0 mm carbide blade was packaged in a 0.9 mm carbide blade packaging. |
| Root cause | 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 | 2500 burs |
| Distribution | US: NV, PA, FL, SC, IA, NC- |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.