Z-1997-2009

MDI Hybrid Implant, O-Ball abutment, sizes 2.9mm x 13mm and 2.9mm x 15mm, endosseous dental implant. The...

Name: Z-1997-2009 MDI Hybrid Implant, O-Ball abutment, sizes 2.9mm x 13mm and 2.9mm x 15mm, endosseous dental implant. The...
Creator: IMTEC Corporation
Published: 2009-07-07
License: https://open.fda.gov/license/

3M Imtec / initiated 2009-07-07 / Terminated / root cause: packaging

FDA source

IMTEC Corporation began a recall of 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 on 2009-07-07. The reason FDA records is "Size printed on product packaging does not match size of enclosed product". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1997-2009
Status: Terminated
Initiated: 2009-07-07
Posted: 2009-09-10
Terminated: 2009-12-02
Recalling firm: 3M Imtec
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.
Product code: KKO Ring, Teething, Fluid-Filled
Reason for recall: Size printed on product packaging does not match size of enclosed product.
Root cause tag: packaging
FDA 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 in commerce: 605 units
Distribution: Worldwide -- US, Azerbaijan, Guatemala, Turkey, and Germany.
Product codes and lots: Lot numbers for product code MII-OB13: 3503092-43 and 3503093-19. Lot number for product code MII-OB15: 352092-56.

Product code KKO

K081653Class IIMdi Mii One-Piece Implant, 2.9MmImtec Corp. / cleared 2008-09-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)