FDA Recall Open, Classified

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:

Recall: Z-0493-2020 · Initiated November 7, 2018

Recall

Recall Number
Z-0493-2020
Event Number
83776
Firm
Hager & Meisinger Gmbh Ronsdorferstrasse 22 Dusseldorf Germany
FEI Number
8010516
Product Code
EJL
Status
Open, Classified
Root Cause
Employee error
Initiated
November 7, 2018

Description

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:

Reason

Incorrect packaging; There is a potential that a 1.0 mm carbide blade was packaged in a 0.9 mm carbide blade packaging.

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

Distribution

US: NV, PA, FL, SC, IA, NC-

Quantity

2500 burs