Z-0455-2019 Class II Terminated
FDA device recall Z-0455-2019 was initiated by Straumann Manufacturing, Inc. on October 2, 2018 and is designated Class II. Reason for recall: Laser engraved label does not match with the item in the package The recall status is terminated (terminated January 28, 2019). Affected quantity: 21 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 21, 2018
- Initiation Date
- October 2, 2018
- Termination Date
- January 28, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 21 units
Product 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 for Recall
Laser engraved label does not match with the item in the package
Distribution Pattern
US nationwide distribution in the states of GA, TX , VA.
Code Information
Lot Number: 800327510 UDI: (01)07899878026488(11)171110(17)221110(10)800327510