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Medical Devices Sector
قطاع الأجهزة الطبية
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
mdprc 114 12 15 000
NexGen Precoat Tibial Plate, NexGen Option Tibial Plate
Orthopaedic prosthesis implantation instrument, reusable
Medical Device Identifier:
NexGen Precoat Tibial Plate (part: 00-5980-037-01, lot: 62491580) NexGen Option Tibial Plate (part: 00-5986-037-01, lot: 62460315)
Reason of Field Safety Corrective Action:
Zimmer Biomet is initiating a lot specific recall of the NexGen Precoat Tibial Plate and NexGen Option Tibial Plate due to a commingle between the affected lots of the same size tibial components. A field complaint was received indicating the NexGen Option Tibial Plate from lot 62460315 was found in the package for a NexGen Precoat Tibial Plate from lot 62491580
Locate all affected product identified above and quarantine them immediately.
Ebrahim M. Al-Mana & Bros. Co. Ltd.
Source Ref. Number:
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
ZFA 2015-151 Distributor LetterNexGen Precoat Tibial Plate_EN.pdf
Copyright © 2008 Saudi Food and Drug Authority. All rights reserved.