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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 021 04 12 000
Date submitted: 4/10/2012
Manufacturer:Stryker Trauma AG
Device Type:Medullary canal orthopaedic reamer, rigid, Combo Reamer Drill, Combo Reamer Assembly
Description:Medullary canal orthopaedic reamer, rigid
Medical Device Identifier:Serial no.: 704005, 704005‐10, 704006 Lot/batch no.: see attached list
Reason of Field Safety Corrective Action:Stryker Osteosynthesis has become aware of the fact that the cutting performance of the Combo Reamer Drill might be not as expected which could increase the time for drilling during the surgery or even make it necessary to exchange the instrument or to change to another OP technique.
Remedy Action:Immediately check all stock areas or operating room storage and quarantine any affected product(s) found, return it to Stryker.
Athorized Representative/Importer/Distributor: Al-Faisaliah Medical System, Riyadh, (01) 2119948
Report Source:NCAR
Source Ref. Number:CH-2012-04-03-015
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: stryker.pdf