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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 087 03 11 000
Date submitted: 3/22/2011
Manufacturer:Synthes Inc
Device Type:PlivioPore
Description:PlivioPore is an implant system for posterior lumbar intercorporeal fusion.
Medical Device Identifier:( Lot numbers are attached) PlivioPore, size 7 mm, sterile 495.037S PlivioPore, size 9 mm, sterile 495.039S PlivioPore, size 10 mm, sterile 495.040S PlivioPore, size 11 mm, sterile 495.041S PlivioPore, size 12 mm, sterile 495.042S PlivioPore, size 13 mm, sterile 495.043S PlivioPore, size 15 mm, sterile 495.045S
Reason of Field Safety Corrective Action:The labels on PlivioPore implants do not reflect the actual shelf life as foreseen.
Remedy Action:This corrective action is a proactive measure so that all incorrectly labelled (10 years shelf life instead of 5 years) PlivioPore implants are not used after the validated shelf life. all devices should be exchanged in the field.
Athorized Representative/Importer/Distributor:Isam Economic Co., Riyadh, (01) 4600846
Report Source:NCAR
Source Ref. Number:CH-2011-03-18-011
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:No Attachments