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Medical Devices Sector
قطاع الأجهزة الطبية
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 133 10 18 000
Date submitted: 10/24/2018
Manufacturer:Zimmer, INC
Device Type:RapidFlap System SpinDown Clamps
Description:Clamps, Surgical, Bone, Plate Holding
Medical Device Identifier:Item Number: 75-1020 75-1020-12, 75-1030, 75-1030-12, 75-1040, 75-1040-12
Reason of Field Safety Corrective Action:Zimmer Biomet states that the nut that interfaces with the outer plate of the above clamps may be misassembled, potentially leading to a delay in surgery or intervention necessitated by postoperative device failure.
Remedy Action:Identify and isolate any affected product in your inventory. Depending on your geographic region and whether your facility purchased affected product by direct sale or consignment, either your Zimmer Biomet sales representative will remove affected product from your facility or your facility must return product directly to Zimmer Biomet.
Athorized Representative/Importer/Distributor:Medical Regulations Gate
Report Source:BfArM
Source Ref. Number:A31542(ECRI), 13090/18
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Zimmer, INC.pdf