FDA Medical Device Recalls (openFDA)
Straumann Manufacturing, Inc.: Neodent GM Mini Conical Abutment - Product Usage: Mini Conical Abutments are intermediary prosthetic components to be installed onto GM implants to support the final prosthesis. They are provided in a rotational shape for the coupling with the prosthesis and in different gingival heights to match the variations in mucosal thickness. The GM Exact Mini Conical abutment is provided angled. They are indicated for screw-retained multiple-unit prostheses onto implants Article Number: 115244
- Recall number
- Z-0455-2019
- Recalling firm
- Straumann Manufacturing, Inc.
- Product
- Neodent GM Mini Conical Abutment - Product Usage: Mini Conical Abutments are intermediary prosthetic components to be installed onto GM implants to support the final prosthesis. They are provided in a rotational shape for the coupling with the prosthesis and in different gingival heights to match the variations in mucosal thickness. The GM Exact Mini Conical abutment is provided angled. They are indicated for screw-retained multiple-unit prostheses onto implants Article Number: 115244
- Status
- Terminated
- Initiated
- 2018-10-02
- Posted
- not on file
- Terminated
- 2019-01-28
- Reason
- Laser engraved label does not match with the item in the package
- Root cause
- Employee error
- Action
- Straumann sales reps. visited each account, retrieved and returned product to Straumann USA.
- Quantity
- 21 units
- Distribution
- US nationwide distribution in the states of GA, TX , VA.
- Lot, serial or model codes
- Lot Number: 800327510 UDI: (01)07899878026488(11)171110(17)221110(10)800327510
- 510(k) numbers
- K163194
- 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
- 3e6df46828c1
- Size
- 288213574 bytes
- Published
- 2026-10-06
- Read
- 2026-10-07T03:20:25.099Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-14
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 3e6df46828c1, published 2026-10-06