| Class 2 Device Recall Neodent GM x 4mm Healing Abutment | |
Date Initiated by Firm | July 18, 2023 |
Date Posted | October 24, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-0153-2024 |
Recall Event ID |
92867 |
510(K)Number | K220823 |
Product Classification |
Abutment, implant, dental, endosseous - Product Code NHA
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Product | Preat REF 9007123, Neodent GM x 4mm Healing Abutment, Rx Only, Non-Sterile, Single Use Only. Dental |
Code Information |
UDI-DI: 00842092161388/Lot #OF018357 |
Recalling Firm/ Manufacturer |
Preat Corp 2625 Skyway Dr Ste B Santa Maria CA 93455-1405
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For Additional Information Contact | Nichole 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 |
Action | On 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 Commerce | 23 units |
Distribution | US: FL, CA, OR, TX, OH, CA, SC, OR, NJ, SC,
OUS: None |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = NHA
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