RecallDepth

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.

Company
3M Espe Dental Products
Recall Initiated
February 12, 2007
Posted
May 11, 2007
Terminated
February 24, 2008
Recall Number
Z-0800-2007
Quantity
99
Firm Location
Irvine, CA

Reason for Recall

Cement in 3M ESPE RelyX Veneer Cement Refill A3 Shade syringes, may not cure to the degree expected.

Distribution

Worldwide distribution ---- USA including states of IN, PA, NY, CA, NV, AZ and country of Malaysia.

Lot / Code Info

7CG code on syringe (Lot 20070124 on box/bag)

Root Cause

Other

Action Taken

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.