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U.S. Department of Health and Human Services

Class 2 Device Recall Neodent GM x 4mm Healing Abutment (Wide)

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 Class 2 Device Recall Neodent GM x 4mm Healing Abutment (Wide)see related information
Date Initiated by FirmJuly 18, 2023
Date PostedOctober 24, 2023
Recall Status1 Open3, Classified
Recall NumberZ-0154-2024
Recall Event ID 92867
510(K)NumberK220823 
Product Classification Abutment, implant, dental, endosseous - Product Code NHA
ProductPreat REF 9007124, Neodent GM x 4mm Healing Abutment (Wide), Rx Only, Non-Sterile, Single Use Only. Dental
Code Information UDI-DI: 00842092161395/Lot #OF018355
Recalling Firm/
Manufacturer		 Preat Corp
2625 Skyway Dr Ste B
Santa Maria CA 93455-1405
For Additional Information ContactNichole Fetterman
805-623-1401
Manufacturer Reason
for Recall		The healing abutments contain a dimensional condition that may lead to a gap between the healing abutment and the implant allowing for microleakage
FDA Determined
Cause 2		Process change control
ActionOn August 4, 2023, Preat Corporation issued a "Urgent Medical Device Recall" notification via: USPS. Preat ask consignees to take the following actions: Product within the scope of the recall shall be discarded or returned to Preat Corporation. Instructions for the return will be provided. Complete and email response form to Nichole Fetterman, E-Mail: nfetterman@younginnovations.com or mail to Preat Corporation, Attn. Nichole Fetterman, 2625 Skyway Drive, Ste. B, Santa Maria, CA 93455
Quantity in Commerce4 units
DistributionUS: FL, CA, OR, TX, OH, CA, SC, OR, NJ, SC, OUS: None
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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