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U.S. Department of Health and Human Services

Class 2 Device Recall Neodent GM X 6mm Engaging Titanium Base

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 Class 2 Device Recall Neodent GM X 6mm Engaging Titanium Basesee related information
Date Initiated by FirmFebruary 21, 2023
Date PostedMarch 24, 2023
Recall Status1 Open3, Classified
Recall NumberZ-1285-2023
Recall Event ID 91876
510(K)NumberK220823 
Product Classification Abutment, implant, dental, endosseous - Product Code NHA
ProductNeodent GM X 6mm Engaging Titanium Base, REF: 9007162
Code Information UDI: 00842092161326, Lots: 211891 and 211912
FEI Number 2918719
Recalling Firm/
Manufacturer		 Preat Corp
2625 Skyway Dr Ste B
Santa Maria CA 93455-1405
For Additional Information ContactNichole Fetterman
800-232-7732
Manufacturer Reason
for Recall		Engaging titanium base contains a dimensional condition that allows vertical movement of the titanium base after the prosthetic screw is torqued to the recommended value, which if undetected and installed on the implant, may lead to abutment/screw fracture, which could result in the abutment/screw/crown being ingested by the patient.
FDA Determined
Cause 2		Process design
ActionOn 2/21/23, recall notices were mailed to customers who were asked to discard or return affected devices to the recalling firm. In addition, in the event affected product was further distributed, customers were asked to inform their customers, or to provide a customer list so the recalling firm could notify these additional customers. The customer service number was provided: 800-232-7732
Quantity in Commerce26
DistributionUS Nationwide distribution in the states of TX, OR, UT, NY.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = NHA
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