FDA Medical Device Recalls (openFDA)
Thommen Medical, AG: SPI EASY Abutment. Endosseous dental implant abutment.
- Recall number
- Z-1086-2007
- Recalling firm
- Thommen Medical, AG
- Product
- SPI EASY Abutment. Endosseous dental implant abutment.
- Status
- Terminated
- Initiated
- 2007-04-19
- Posted
- 2007-07-24
- Terminated
- 2008-05-12
- Reason
- 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.
- 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
- 84
- Distribution
- Nationwide.
- Lot, serial or model codes
- #4_03_700 Batch 8007 REF: 1.03.700 LOT: 5121
- 510(k) numbers
- ["K023645"]
- PMA numbers
- not on file
- Product code
- DZE
- Firm FEI
- 3003836985
- Firm city
- Waldenburg
- Firm state
- not on file
- Firm country
- Switzerland
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
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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