3M ESPE Rely X Veneer Cement Refill Syringes, A3 Opaque/Yellow Opaque Shade, manufactured by 3M. ESPE is a radiopaque ,
FDA device recall Z-0800-2007 · posted 2007-05-11 · Terminated
Recall details
- Recalling firm
- 3M Espe Dental Products
- Reason for recall
- Cement in 3M ESPE RelyX Veneer Cement Refill A3 Shade syringes, may not cure to the degree expected.
- Action taken
- 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
- Status
- Terminated
- Product code
- EBF
- Quantity affected
- 99
- Distribution
- Worldwide distribution ---- USA including states of IN, PA, NY, CA, NV, AZ and country of Malaysia.
- Date initiated
- 2007-02-12
- Date posted
- 2007-05-11
- Date terminated
- 2008-02-24
- Location
- Irvine, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| 3M LVR SYSTEM (K991961) | 3M Company | 1999-08-09 |