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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 abutmentsee related information
Date Initiated by FirmOctober 02, 2018
Create DateNovember 14, 2018
Recall Status1 Terminated 3 on January 28, 2019
Recall NumberZ-0455-2019
Recall Event ID 81456
510(K)NumberK163194 
Product Classification Implant, endosseous, root-form - Product Code DZE
ProductNeodent 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
ActionStraumann sales reps. visited each account, retrieved and returned product to Straumann USA.
Quantity in Commerce21 units
DistributionUS nationwide distribution in the states of GA, TX , VA.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = DZE
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