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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 119 06 13 000
Date submitted: 6/25/2013
Manufacturer:3M Health Care Ltd
Device Type:Dental product, Unitek™ Primary ,Stainless Steel Crowns - Series UR4
Description:Dental product, Unitek™ Primary ,Stainless Steel Crowns - Series UR4
Medical Device Identifier:Product Code 902150 (Kit) • Lot Codes N484233 and N463186 Product Code 900224 (Refill) • Lot codes N466509 and N473723
Reason of Field Safety Corrective Action:The subject lots of UR4 crown kits and refills contain LL3 crowns which are incorrectly labeled as UR4 crowns.
Remedy Action:3M ask you that review your inventory of Unitek Stainless Steel Crowns for products from these lot numbers. If you identify product from these lots in your inventory, please quarantine the product and do not further distribute. To initiate product return and replacement,
Athorized Representative/Importer/Distributor:3M Health Care Ltd , Riyadh , (011) 4650052
Report Source:NCMDR
Source Ref. Number:ED7D5BCF0829C
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company
Attachments: 3M Health Care Ltd.pdf