Recall Z-0800-2007 ยท EBF Material, Tooth Shade, Resin
3M Espe Dental Products
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.
| Date | May 11, 2007 (initiated Feb 12, 2007) |
| Status | Terminated |
| Reason | Cement in 3M ESPE RelyX Veneer Cement Refill A3 Shade syringes, may not cure to the degree expected. |
| Root 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 | 99 |
| Distribution | Worldwide distribution ---- USA including states of IN, PA, NY, CA, NV, AZ and country of Malaysia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K991961 | 3M LVR SYSTEM 3M Company, Aug 9, 1999 |