MDI Hybrid Implant, O-Ball abutment, sizes 2.9mm x 13mm and 2.9mm x 15mm, endosseous dental implant. The product is used
FDA device recall Z-1997-2009 · posted 2009-09-10 · Terminated
Recall details
- Recalling firm
- IMTEC Corporation
- Reason for recall
- Size printed on product packaging does not match size of enclosed product.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- KKO
- Quantity affected
- 605 units
- Distribution
- Worldwide -- US, Azerbaijan, Guatemala, Turkey, and Germany.
- Date initiated
- 2009-07-07
- Date posted
- 2009-09-10
- Date terminated
- 2009-12-02
- Location
- Ardmore, OK
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MDI MII ONE-PIECE IMPLANT, 2.9MM (K081653) | Imtec Corp. | 2008-09-19 |