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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCAR Recall
Reference Number: mdprc 128 06 12 000
Date submitted: 6/24/2012
Manufacturer:Rudolf Medical GmbH & Co. KG
Device Type:OP-hammer, OP-Mallet, stainless steel hammer head and aluminum shaft.
Description:OP-hammer.
Medical Device Identifier:OP-Mallet, OP-Hammer ; RU 5799-18, RU 5800-23, RU 5802-24, RU 5804-24, RU 5805-18, RU 5806-24, RU 5807-00/00, RU 5809-19 Software version: Nicht zutreffend. Lot/batch no: XXX324 und XXX505
Reason of Field Safety Corrective Action:The manufacturer Rudolf Medical GmbH informed about a FSCA with the a.m. OP-Mallet. The devices with a combination of stainless steel hammer head and aluminum shaft (only affected with ID Codes XXX505 or XXX324) may break.
Remedy Action:The manufacturer recalled all affected devices and offered faultless replacement devices
Athorized Representative/Importer/Distributor:N/A
Report Source:NCAR
Source Ref. Number:DE-BfArM-2012-06-19-121
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:No Attachments