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U.S. Department of Health and Human Services

Class 2 Device Recall Astra EV 4.8mm Milled Titanium Abutment

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  Class 2 Device Recall Astra EV 4.8mm Milled Titanium Abutment see related information
Date Initiated by Firm April 10, 2024
Date Posted July 08, 2024
Recall Status1 Open3, Classified
Recall Number Z-2318-2024
Recall Event ID 94693
510(K)Number K220823  
Product Classification Abutment, implant, dental, endosseous - Product Code NHA
Product 9006767 Astra EV 4.8mm Milled Titanium Abutment

Milled abutments are too be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.
Code Information Model Number: 9006767 UDI-DI code: 00842092159477 Lot Numbers: ED11-20247825, ED11-20248895, ED11-20249165 and 241588
Recalling Firm/
Manufacturer
Preat Corp
2625 Skyway Dr Ste B
Santa Maria CA 93455-1405
For Additional Information Contact Jose Espino
224-622-7191
Manufacturer Reason
for Recall
Due to incorrect milled titanium abutment being packaged and labeled.
FDA Determined
Cause 2
Process control
Action On 05/21/2024, the firm sent via direct certified mail an "URGENT: MEDICAL DEVICE RECALL UPDATE" Letter to customers informing them that product labeled as part number 9006767-F Astra EV 4.8mm Milled Titanium Abutment may contain instead part number 9006667 Astra EV 4.2mm Milled Titanium Abutment. The potential risk identified was, the screw seat is higher than specified in the engineering drawings and required for full thread engagement with the implant. This condition reduces the screw thread engagement with the implant. Customer are instructed to: Product in the scope of this recall shall be discarded or returned to PREAT CORPORATION. Instructions for the return will be provided. All personnel within your company should be made aware of the issue. Any customers to which this product has been further distributed should be notified. For questions or assistance contact Jose Espino at 224-622-7191 or email jespino@younginnovations.com
Quantity in Commerce 7 abutmens
Distribution U.S.: CA, MO, and NV. O.U.S.: None
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = NHA and Original Applicant = Preat Corporation
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