Singles carbides by Meisinger…

Date

Nov. 27, 2019

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Ongoing

Filed by

Hager & Meisinger Gmbh

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:

Reason

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

Distribution pattern

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

Quantity

2500 burs

Codes and lots

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

Recall started

Nov. 7, 2018

Device type

Bur, Dental

Root cause (FDA)

Employee error

What the company told customers

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

Recall number

Z-0493-2020

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-0493-2020. The agency record governs; check it and the company before acting.