RecallDepth

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:

Company
Hager & Meisinger Gmbh Ronsdorferstrasse 22 Dusseldorf Germany
Recall Initiated
November 7, 2018
Recall Number
Z-0493-2020
Quantity
2500 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.

Distribution

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

Lot / Code Info

Lot #R23891 UDI: +E0HM26UN2453140099/$$8250523R23891+

Root Cause

Employee error

Action Taken

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