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:
FDA Recall Z-0493-2020 · Posted None
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Recalling FirmHager & Meisinger Gmbh
Recall StatusOpen, Classified
Product CodeEJL
Date Initiated2018-11-07
Product Quantity2500 burs
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.
Firm 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 [email protected]
4. For further questions, our customer service is available at +1 (303)268-5407
Root Cause
Employee error
Distribution Pattern
US: NV, PA, FL, SC, IA, NC-
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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