Recall Z-0455-2019— Straumann Manufacturing, Inc.
Class II · Terminated
Class II FDA medical device recall by Straumann Manufacturing, Inc., initiated 2018-10-02, terminated 2019-01-28. It names one FDA 510(k) clearance: K163194. 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. Reason: Laser engraved label does not match with the item in the package.
- Recalling firm
- Straumann Manufacturing, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-10-02
- Terminated
- 2019-01-28
- Firm location
- Andover, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.