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U.S. Department of Health and Human Services

Class 2 Device Recall Astra EVcompatible 4.2mm Digital Analog

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 Class 2 Device Recall Astra EVcompatible 4.2mm Digital Analogsee related information
Date Initiated by FirmJune 24, 2025
Date PostedJuly 10, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2107-2025
Recall Event ID 97136
510(K)NumberK220823 
Product Classification Abutment, implant, dental, endosseous - Product Code NHA
ProductPreat, Astra EV-compatible 4.2mm Digital Analog REF: 9006603 (single) and 9006603-10(10 pack), Rx Only
Code Information Lots: 278735, & 278402/UDI:
FEI Number 2918719
Recalling Firm/
Manufacturer		 Preat Corp
2625 Skyway Dr Ste B
Santa Maria CA 93455-1405
For Additional Information ContactMarlen Gonzels
805-623-1401
Manufacturer Reason
for Recall		Due to manufacturing error, digital analog rotational feature is 180 degrees off.
FDA Determined
Cause 2		Employee error
ActionOn June 24, 2025 Preat Corporation issued a "Urgent: Medical Device Recall" to affected consignees via certified mail. Preat asked consignees to take following actions: 1. Immediately review your inventory for product listed in the table below. 2. Customers shall stop/cease use of the product in the scope of this recall. 3. It shall be discarded or returned to PREAT CORPORATION. Instructions for the return will be provided. 4. All personnel within your company should be made aware of the issue. Any customers to which this product has been further distributed should be provided a copy of this notification and informed to notify their customers. 5. Complete and return the Customer Response Form following completion of your reconciliation activities.
Quantity in Commerce44 units
DistributionUS Nationwide distribution in the states of AL, CA, FL, GA, KY, MD, MN, NY, OK, PA.
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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