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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 086 06 11 000
Date submitted: 6/25/2011
Manufacturer:Zimmer inc
Device Type:Prosthesis, Acetabulum prosthesis
Description:Prosthesis, Acetabulum prosthesis
Medical Device Identifier:PE Alpha Hooded Insert HH/28; Model 01.00010.308; Lot 2463499 PE Alpha Hooded Insert LL/28; Model 01.00010.312; Lot 2462484 Durasul alpha Insert Neutral KK/36; Model 01.00013.711; Lot 2541553 Durasul Alpha Insert With Rim II/28; Model 01.00013.309; Lot 2541785 Durasul Alpha Insert Neutral GG/28; Model 01.00013.207; Lot 2541769 Durasul Alpha Insert With Rim MM/28; Model 01.00013.313; Lot 2541789
Reason of Field Safety Corrective Action:The packages contained the wrong patient label. Where the wrong patient label is being used for documentation of the implanted device, the wrong lot and size will be recorded in the patient record. With later inquiries, this could potentially lead to an incorrectly prepared revision surgery (wrong size insert selected).
Remedy Action:Remove affected devices from the field and to provide additional patient labels to correct possibly wrong recorded patient records. If devices have already been implanted, Zimmer GmbH will provide correct patient labels in order to correct the patient records if necessary.
Athorized Representative/Importer/Distributor:Ebrahim M. Al-Mana & Bros. Co. Ltd., Riyadh, (01) 4610733
Report Source:NCAR
Source Ref. Number:CH-2011-06-15-022
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:No Attachments