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Medical Devices Sector
قطاع الأجهزة الطبية
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 112 03 17 000
Date submitted: 3/29/2017
Manufacturer:Zimmer Biomet
Device Type:Zimmer Specific Knee, Hip and Nail Implants
Description:Prostheses, Joint, Hip, Femoral Component
Medical Device Identifier:Multiple affected item numbers are provided in the attached FSN.
Reason of Field Safety Corrective Action:Zimmer is initiating a field action for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures. Specifically, multiple test samples from each of the two configurations failed simulated distribution and shipping testing. The devices impacted are generally the heaviest outlier sizes within the respective product family. Below are photos representative of failures seen during this testing.
Remedy Action:Return the affected device(s) to the manufacturer.
Athorized Representative/Importer/Distributor:Ebrahim M. Al-Mana & Bros. Co. Ltd.
Report Source:NCMDR
Source Ref. Number:A8311EC17522D
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Zimmer Biomet.pdf