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Medical Devices Sector
قطاع الأجهزة الطبية
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCAR Recall
Reference Number: mdprc 043 10 12 000
Date submitted: 10/15/2012
Manufacturer:Synthes Inc
Device Type:Craniofacial bone distractor, Mandible Distractor Multiaxial
Description:Craniofacial bone distractor
Medical Device Identifier:Part Number (Part Description; Lot Number): 487.931 (Distractor Body, Titanium Alloy (TAV); 7895264, 7793390, 7583381, 7583380, 7528840, 3708643, 3683421, 3683403, 3560888); 487.966 (Mandible Distractor, multiaxial, right, Titanium Alloy (TAV); 7765627, 7562081, 7532790, 3800757, 3757207); 487.967 (Mandible Distractor, multiaxial, left, Titanium Alloy (TAV); 7834374, 7662788, 7562083, 3757213, 3739743)
Reason of Field Safety Corrective Action:A reported complaint of missing outer sheer pin. The inner diameter (for fixing the sheer pin) of the worm gear component was out of specification.
Remedy Action:For patients who may be undergoing treatment with this device, it is advised to contact the patient to check if the device they have is one of the effected lots see attached. Synthes decided to remove all potential affected parts from the field. Synthes is requesting that you immediately cease using the product and please examine your inventory for the above effected lot numbers and remove them. When in doubt, please remove the product and provide it to your Synthes Sales Representative.
Athorized Representative/Importer/Distributor:Isam Economic Co., Riyadh, (01) 4600846
Report Source:NCAR
Source Ref. Number:CH-2012-10-04-055
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Synthes Inc.pdf