FDA Medical Device Recalls (openFDA)
Straumann Manufacturing Inc: RN synOcta Meso Abutment, crown margin 8.0mm, Ti Article: 048.560
- Recall number
- Z-0975-05
- Recalling firm
- Straumann Manufacturing Inc
- Product
- RN synOcta Meso Abutment, crown margin 8.0mm, Ti Article: 048.560
- Status
- Terminated
- Initiated
- 2005-06-06
- Posted
- 2005-07-07
- Terminated
- 2005-11-03
- Reason
- Basal screw is too short to adequately hold the dental abutment in the implant
- 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
- 23
- Distribution
- AZ, CA, DE, FL, NY, OH, OK, TX
- Lot, serial or model codes
- Lot Number: 1007
- 510(k) numbers
- ["K020096"]
- PMA numbers
- not on file
- Product code
- DZE
- Firm FEI
- 1000121052
- Firm city
- Andover
- Firm state
- MA
- Firm country
- not on file
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
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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