Astra EV Titanium Abutment (Preat) – incorrect packaging (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Preat Corp
Lot Codes / Batch Numbers
Model Number: 9006767 UDI-DI code: 00842092159477 Lot Numbers: ED11-20247825, ED11-20248895, ED11-20249165 and 241588
Products Sold
Model Number: 9006767 UDI-DI code: 00842092159477 Lot Numbers: ED11-20247825, ED11-20248895, ED11-20249165 and 241588
Preat Corp is recalling 9006767 Astra EV 4.8mm Milled Titanium Abutment Milled abutments are too be used in conjunction wit due to Due to incorrect milled titanium abutment being packaged and labeled.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Due to incorrect milled titanium abutment being packaged and labeled.
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, MO, NV
Page updated: Jan 10, 2026