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Medical Devices Sector
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NCAR Recall
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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
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Copyright © 2008 Saudi Food and Drug Authority. All rights reserved.