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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 090 10 11 000
Date submitted: 10/30/2011
Manufacturer:Newdeal SAS
Device Type:SURFIX ALPHA SCREW
Description:SCREW, STERILE
Medical Device Identifier:Diameter:2.7mm*length14mm - STERILE Model: 295214S Lot/batch no.: EGH9
Reason of Field Safety Corrective Action:Newdeal SAS has recently become aware that certain screws of one batch of SURFIX® ALPHA SCREW diameter 2.7mm (Catalog number 295214S – batch EGH9) have been etched and labeled with (length): inadequate specifications Some 12 mm long screws are etched with reference and batch corresponding to 14mm long screws.
Remedy Action:Newdeal SAS will contact you upon receipt of this information to organize the return of the affected products and will bear the costs of the products exchanged and related transport.
Athorized Representative/Importer/Distributor:N/A
Report Source:NCAR
Source Ref. Number:FR-2011-10-24-054
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:No Attachments