Class 2 Device Recall Rely X

• Date Initiated by Firm: February 12, 2007
• Date Posted: May 11, 2007
• Recall Status: Terminated on February 24, 2008
• Recall Number: Z-0800-2007
• Recall Event ID: 37635
• 510(K)Number: K991961
• Product Classification: Dental Cement - Product Code EBF
• Product: 3M ESPE Rely X Veneer Cement Refill Syringes, A3 Opaque/Yellow Opaque Shade, manufactured by 3M. ESPE is a radiopaque , color stable light-cured resin cement indicated for bonding veneers fabricated of porcelainor composite.
• Code Information: 7CG code on syringe (Lot 20070124 on box/bag)
• Recalling Firm/ Manufacturer: 3M Espe Dental Products; 2111 Mcgaw Ave; Irvine CA 92614-0908
• Manufacturer Reason for Recall: Cement in 3M ESPE RelyX Veneer Cement Refill A3 Shade syringes, may not cure to the degree expected.
• FDA Determined Cause: Other
• Action: All consignees including distributors were notified of the recall via telephone or mail on 2/27/2007. Communication with distributors included the product being recalled, the problem , recommended stop usage or distribution and directions for return shippment. Further, the consignees were also sent a letter which described the product and problem and what to do if the product was still availabe or had been used.
• Quantity in Commerce: 99
• Distribution: Worldwide distribution ---- USA including states of IN, PA, NY, CA, NV, AZ and country of Malaysia.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = EBF