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U.S. Department of Health and Human Services

Class 2 Device Recall Endosseous dental implant abutment

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  Class 2 Device Recall Endosseous dental implant abutment see related information
Date Initiated by Firm October 02, 2018
Create Date November 14, 2018
Recall Status1 Terminated 3 on January 28, 2019
Recall Number Z-0455-2019
Recall Event ID 81456
510(K)Number K163194  
Product Classification Implant, endosseous, root-form - Product Code DZE
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
Code Information Lot Number: 800327510 UDI: (01)07899878026488(11)171110(17)221110(10)800327510
Recalling Firm/
Manufacturer		 Straumann Manufacturing, Inc.
60 Minuteman Rd
Andover MA 01810-1008
For Additional Information Contact
978-747-2500
Manufacturer Reason
for Recall		 Laser engraved label does not match with the item in the package
FDA Determined
Cause 2		 Employee error
Action Straumann sales reps. visited each account, retrieved and returned product to Straumann USA.
Quantity in Commerce 21 units
Distribution US nationwide distribution in the states of GA, TX , VA.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DZE and Original Applicant = JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS SA
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