FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-0800-2007
- 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.
- Status
- Terminated
- Initiated
- 2007-02-12
- Posted
- 2007-05-11
- Terminated
- 2008-02-24
- 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.
- Lot, serial or model codes
- 7CG code on syringe (Lot 20070124 on box/bag)
- 510(k) numbers
- ["K991961"]
- PMA numbers
- not on file
- Product code
- EBF
- Firm FEI
- 2020493
- Firm city
- Irvine
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28