Recall Z-1997-2009
IMTEC Corporation · initiated July 7, 2009
Product
MDI Hybrid Implant, O-Ball abutment, sizes 2.9mm x 13mm and 2.9mm x 15mm, endosseous dental implant. The product is used as a endosseous dental implant.
Codes / lots: Lot numbers for product code MII-OB13: 3503092-43 and 3503093-19. Lot number for product code MII-OB15: 352092-56.
Reason for recall
Size printed on product packaging does not match size of enclosed product.
FDA-determined cause: Other
Action taken
A notification letter dated July 7, 2009 was issued to customers. The letter described the issue and instructed customers do not use the affected product and call IMTEC, a 3M Company, at 1-800-879-9799, extension 240 for assistance. Customers were further instructed to complete the enclosed Recall Response Fax-Back Form with information on their inventory (whether or not the recalled product is in their stock). The firm's representative will follow-up with customers if no response within three business days of receiving the notification letter.
Details
- Recall number
- Z-1997-2009
- Initiated
- July 7, 2009
- Posted by FDA
- September 10, 2009
- Terminated
- December 2, 2009
- Product code
- KKO – Ring, Teething, Fluid-Filled
- Quantity
- 605 units
- Distribution
- Worldwide -- US, Azerbaijan, Guatemala, Turkey, and Germany.
- Recalling firm
- IMTEC Corporation, Ardmore, OK