Z-1703-2010

S1813OB 1.8X13mm Sendax MDI Mini Dental Implant O-Ball Prosthetic Head

Name: Z-1703-2010 S1813OB 1.8X13mm Sendax MDI Mini Dental Implant O-Ball Prosthetic Head
Creator: 3m Imtec Corporation
Published: 2010-05-14
License: https://open.fda.gov/license/

3M Imtec / initiated 2010-05-14 / Terminated / root cause: packaging

FDA source

3m Imtec Corporation began a recall of S1813OB 1.8X13mm Sendax MDI Mini Dental Implant O-Ball Prosthetic Head on 2010-05-14. The reason FDA records is "Product has Incorrect size Labeling. Actual length is 13mm. One label is correct, and one states 10mm". 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-1703-2010
Status: Terminated
Initiated: 2010-05-14
Posted: 2010-05-27
Terminated: 2010-07-14
Recalling firm: 3M Imtec
Product: S1813OB 1.8X13mm Sendax MDI Mini Dental Implant O-Ball Prosthetic Head
Product code: DZE Implant, Endosseous, Root-Form
Reason for recall: Product has Incorrect size Labeling. Actual length is 13mm. One label is correct, and one states 10mm.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: IMTEC notified consignees by phone on May 14, 2010 and by Certified Letter dated May 14, 2010.
Quantity in commerce: 189 Implants
Distribution: Nationwide.
Product codes and lots: Lot #035D10188

Product code DZE

K031106Class IIImtec Sendax Mdi and Mdi Plus Endosseous Implant, Models Ob-Xx, Sh-Xx, Mob-22, Msh-XxImtec Corp. / cleared 2003-08-12

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)