FDA Recall
Terminated
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: Z-0455-2019
·
Initiated October 2, 2018
Recall
- Recall Number
- Z-0455-2019
- Event Number
- 81456
- Firm
- Straumann Manufacturing, Inc.
- FEI Number
- 1000121052
- Product Code
- DZE
- Status
- Terminated
- Root Cause
- Employee error
- Initiated
- October 2, 2018
- Terminated
- January 28, 2019
- Address
- 60 Minuteman Rd, Andover, MA, 01810-1008
Description
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
Reason
Laser engraved label does not match with the item in the package
Action
Straumann sales reps. visited each account, retrieved and returned product to Straumann USA.
Distribution
US nationwide distribution in the states of GA, TX , VA.
Quantity
21 units