Z-1086-2007

SPI EASY Abutment. Endosseous dental implant abutment

Name: Z-1086-2007 SPI EASY Abutment. Endosseous dental implant abutment
Creator: Thommen Medical, AG
Published: 2007-04-19
License: https://open.fda.gov/license/

Thommen Medical AG / initiated 2007-04-19 / Terminated

FDA source

Thommen Medical, AG began a recall of SPI EASY Abutment. Endosseous dental implant abutment on 2007-04-19. The reason FDA records is "The undercut on the SPI EASY abutments which engages the stabilization ring of the implant is missing. Although the abutments can still be placed on the implant by the user the parts do not fulfill the quality...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1086-2007
Status: Terminated
Initiated: 2007-04-19
Posted: 2007-07-24
Terminated: 2008-05-12
Recalling firm: Thommen Medical AG
Product: SPI EASY Abutment. Endosseous dental implant abutment.
Product code: DZE Implant, Endosseous, Root-Form
Reason for recall: The undercut on the SPI EASY abutments which engages the stabilization ring of the implant is missing. Although the abutments can still be placed on the implant by the user the parts do not fulfill the quality expectations of the firm.
FDA root cause: Other
Action: Letter 5/14/2007. Customers are requested to check their current inventory for the recall product. If found they are to return the product for replacement. If they have implanted the product they are to check patient x-rays for the defect. If defects are found they are to do a restoration.
Quantity in commerce: 84
Distribution: Nationwide.
Product codes and lots: #4_03_700 Batch 8007 REF: 1.03.700 LOT: 5121

Product code DZE

K023645Class IISpi Easy Dental Implant AbutmentThommen Medical AG / cleared 2002-11-13

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)