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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 118 12 12 000
Date submitted: 12/18/2012
Manufacturer:Stryker Osteosynthesis
Device Type:Xcelerate Ceramic 4:1 Cutting Blocks.
Description:Cutting Blocks
Medical Device Identifier:SCORPIO: 8000-0003, 8000-0004, 8000-0005, 8000-0006, 8000-0007,8000- 0008,8000-0009,8000-0011,8000-0013 DURACON: 8000-7005, 8000-7010, 8000-7020, 8000-7030, 8000-7040,8000-7050,8000-7060 All lot numbers
Reason of Field Safety Corrective Action:1. Ceramic rail cracks This hazard has no direct-harms but may increase-the charlce of occurrence for other hazards. 2. Ceramic rail (or portion of rail) fully detaches from the block during surgery. 3. Ceramic rail (or portion of rail) detaches from block outside of the operating room.
Remedy Action:Replacement devices are now available and therefore all subject devices which remain in service will be exchanged by with the new design product. (See attached)
Athorized Representative/Importer/Distributor:Al-Faisaliah Medical System, Riyadh, (01) 2119948
Report Source:NCMDR
Source Ref. Number:C44BDF509A2D8
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Stryker Osteosynthesis.pdf