Z-0800-2007

3M ESPE Rely X Veneer Cement Refill Syringes, A3 Opaque/Yellow Opaque Shade, manufactured by 3M. ESPE is a...

Name: Z-0800-2007 3M ESPE Rely X Veneer Cement Refill Syringes, A3 Opaque/Yellow Opaque Shade, manufactured by 3M. ESPE is a...
Creator: 3M Espe Dental Products
Published: 2007-02-12
License: https://open.fda.gov/license/

3M ESPE Dental Products / initiated 2007-02-12 / Terminated

FDA source

3M Espe Dental Products began a recall of 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... on 2007-02-12. The reason FDA records is "Cement in 3M ESPE RelyX Veneer Cement Refill A3 Shade syringes, may not cure to the degree expected". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0800-2007
Status: Terminated
Initiated: 2007-02-12
Posted: 2007-05-11
Terminated: 2008-02-24
Recalling firm: 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.
Product code: EBF Material, Tooth Shade, Resin
Reason for recall: Cement in 3M ESPE RelyX Veneer Cement Refill A3 Shade syringes, may not cure to the degree expected.
FDA 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 in commerce: 99
Distribution: Worldwide distribution ---- USA including states of IN, PA, NY, CA, NV, AZ and country of Malaysia.
Product codes and lots: 7CG code on syringe (Lot 20070124 on box/bag)

Product code EBF

K991961Class II3M Lvr System3M Company / cleared 1999-08-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)