FDA Medical Device Recalls (openFDA)
IMTEC Corporation: 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.
- Recall number
- Z-1997-2009
- Recalling firm
- IMTEC Corporation
- 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.
- Status
- Terminated
- Initiated
- 2009-07-07
- Posted
- 2009-09-10
- Terminated
- 2009-12-02
- Reason
- Size printed on product packaging does not match size of enclosed product.
- Root cause
- Other
- Action
- 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.
- Quantity
- 605 units
- Distribution
- Worldwide -- US, Azerbaijan, Guatemala, Turkey, and Germany.
- Lot, serial or model codes
- Lot numbers for product code MII-OB13: 3503092-43 and 3503093-19. Lot number for product code MII-OB15: 352092-56.
- 510(k) numbers
- ["K081653"]
- PMA numbers
- not on file
- Product code
- KKO
- Firm FEI
- 1000118617
- Firm city
- Ardmore
- Firm state
- OK
- 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