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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
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ational
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enter for
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edical
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evices
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eporting
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NCMDR Recall
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Reference Number:
mdprc 142 06 15 000
Date submitted:
6/24/2015
Manufacturer:
Zimmer inc
Device Type:
Java Hook Implants, Instruments, and Containers
Description:
Implants, Instruments
Medical Device Identifier:
all part and lot numbers of Java Hook implants, instruments and containers See Attachment 1 for a complete list
Reason of Field Safety Corrective Action:
This recall is initiated due to lack of a steam sterilization validation to support the sterilization parameters stated in the Instructions For Use (IFU) (030EAN0000T and 030EAN0000I).
Remedy Action:
1. Review the notification and ensure affected personnel are aware of the contents.
2. Locate all affected product identified in Attachment 1 and quarantine them immediately.
3. Return the recalled product along with the completed Inventory Return Certification Form (Attachment 2).
Athorized Representative/Importer/Distributor:
Ebrahim M. Al-Mana & Bros. Co. Ltd.
Report Source:
NCMDR
Source Ref. Number:
By_E-mail
SFDA Comments:
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:
Zimmer inc.pdf
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