OK Your changes have been successfully saved
SFDA Home Page
Medical Devices Sector
قطاع الأجهزة الطبية
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 095 05 18 000
Date submitted: 5/22/2018
Manufacturer:Zimmer Inc.
Device Type:Echo Instrument Case Shell - Outer Case Vault Only and Comprehensive Reverse Shoulder Instrument - Outer Case Vault Only
Description:Prostheses, Joint, Shoulder, Total
Medical Device Identifier:Product: (Item Number, Lot Number)

1) Echo Instrument Case Shell Tall Outer Case Vaults: ( 595608, All Lots )
2) Comprehensive Primary Shoulder Instrument Outer Case Vaults :595260, All Lots)
3) Comprehensive Primary Shoulder Instrument Case Total Kits: ( 595261, All Lots )
Reason of Field Safety Corrective Action:Zimmer Biomet is conducting a medical device market removal for the Echo Instrument Case Shell Tall Outer Case Vault Only and the Comprehensive Primary Shoulder Instrument Outer Case Vault Only as they do not comply with the weight recommendation in the current ANSI/AAMI ST79 and ISO 17665-2006 standards.
Remedy Action:1.Review this notification and ensure that affected personnel are aware of the contents.
2.Contact your customers using the surgeon/ hospital Field Safety Notice and execute the removal as indicated. Ensure documentation of removal with the customers.
3.Complete Attachment 1 – Inventory Return Certification Form
4.Return a digital copy to fieldaction.export@zimmerbiomet.com. This form must be returned even if you do not have affected products at your facility.
5.Include a copy of Attachment 2 – Certificate of Sterilization with returned instruments
6.Retain a copy of the acknowledgement form with your field action records in the event of a compliance audit of your facility’s documentation.
7.If you have further questions or concerns after reviewing this notice, please contact your Zimmer Biomet representative.
Athorized Representative/Importer/Distributor:Isam Economic Co.
Report Source:NCMDR
Source Ref. Number:CDA0D45CF3390
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Zimmer Biomet.pdf