Date Initiated by Firm |
February 12, 2007 |
Date Posted |
May 11, 2007 |
Recall Status1 |
Terminated 3 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 2 |
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 and Original Applicant = 3M COMPANY
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