Z-0975-05

RN synOcta Meso Abutment, crown margin 8.0mm, Ti Article: 048.560

Name: Z-0975-05 RN synOcta Meso Abutment, crown margin 8.0mm, Ti Article: 048.560
Creator: Straumann Manufacturing Inc
Published: 2005-06-06
License: https://open.fda.gov/license/

Straumann USA, LLC / initiated 2005-06-06 / Terminated

FDA source

Straumann Manufacturing Inc began a recall of RN synOcta Meso Abutment, crown margin 8.0mm, Ti Article: 048.560 on 2005-06-06. The reason FDA records is "Basal screw is too short to adequately hold the dental abutment in the implant". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0975-05
Status: Terminated
Initiated: 2005-06-06
Posted: 2005-07-07
Terminated: 2005-11-03
Recalling firm: Straumann USA, LLC
Product: RN synOcta Meso Abutment, crown margin 8.0mm, Ti Article: 048.560
Product code: DZE Implant, Endosseous, Root-Form
Reason for recall: Basal screw is too short to adequately hold the dental abutment in the implant
FDA root cause: Other
Action: Straumann USA initiated the recall by letter dated 6/6/05. Users are requested to return devices and to examine patients with the implanted device.
Quantity in commerce: 23
Distribution: AZ, CA, DE, FL, NY, OH, OK, TX
Product codes and lots: Lot Number: 1007

Product code DZE

K020096Class IIEsthetic Ease Abutments for the Iti Dental Implant SystemInstitut Straumann AG / cleared 2002-02-08

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)