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Medical Devices Sector
قطاع الأجهزة الطبية
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
mdprc 133 10 18 000
RapidFlap System SpinDown Clamps
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.
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.
Medical Regulations Gate
Source Ref. Number:
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Copyright © 2008 Saudi Food and Drug Authority. All rights reserved.