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.
FDA Recall Z-0800-2007 · Posted 2007-05-11
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Recalling Firm3M Espe Dental Products
Recall StatusTerminated
Product CodeEBF
Date Initiated2007-02-12
Date Terminated2008-02-24
Product Quantity99
Reason for Recall
Cement in 3M ESPE RelyX Veneer Cement Refill A3 Shade syringes, may not cure to the degree expected.
Firm 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.
Root Cause
Other
Distribution Pattern
Worldwide distribution ---- USA including states of IN, PA, NY, CA, NV, AZ and country of Malaysia.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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