3M Espe Dental Products
23 جمادى الاخرة 1428 هـ الموافق 8 يوليو 2007 م
| Recalling Firm / Manufacturer |
3M Espe Dental Products |
| 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) |
| Reason of Recall |
Cement in 3M ESPE RelyX Veneer Cement Refill A3 Shade syringes, may not cure to the degree expected. |
| Date Recall Initiated |
February 12, 2007 |
| 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. Firm Initiated recall is ongoing. |
| Contact |
3M Co.
01 / 2171324 |
| Source of Information |
U.S. FDA |
| SFDA Comments |
SFDA urges all hospitals that have devices subjected to recall, to contact the company. |