X
OK Your changes have been successfully saved
SFDA Home Page
Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCAR Recall
Reference Number: mdprc 081 06 15 000
Date submitted: 6/15/2015
Manufacturer:Zimmer inc
Device Type:Screwdriver blade Cross-Lock Mid 1.7, dental-end
Description:Screwdriver blade
Medical Device Identifier:Lot (16688) Item (503004417)
Reason of Field Safety Corrective Action:Internal investigation found that the Screwdriver blade (2.3 mm) was mislabeled. Following inspection of the product, it was determined that they were erroneously marked as Screwdriver blade Cross-Lock Mid 1.7, dental-end; Lot (16688), Item (503004417).
Remedy Action:Assist your Zimmer sales representative with the quarantine of any affected product. Your Zimmer sales representative will remove the recalled product from your facility.
Athorized Representative/Importer/Distributor:Ebrahim M. Al-Mana & Bros. Co. Ltd.
Report Source:NCAR
Source Ref. Number:FA2015-04
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Zimmer GmbH.pdf