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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 114 12 15 000
Date submitted: 12/27/2015
Manufacturer:Zimmer inc
Device Type:NexGen Precoat Tibial Plate, NexGen Option Tibial Plate
Description: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
Remedy Action:Locate all affected product identified above and quarantine them immediately.
Athorized Representative/Importer/Distributor:Ebrahim M. Al-Mana & Bros. Co. Ltd.
Report Source:NCMDR
Source Ref. Number:By Email
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: ZFA 2015-151 Distributor LetterNexGen Precoat Tibial Plate_EN.pdf