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.
FDA Recall Z-2318-2024 · Posted 2024-07-08
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Recalling FirmPreat Corp
Recall StatusOpen, Classified
Product CodeNHA
Date Initiated2024-04-10
Product Quantity7 abutmens
Reason for Recall
Due to incorrect milled titanium abutment being packaged and labeled.
Firm 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 [email protected]
Root Cause
Process control
Distribution Pattern
U.S.: CA, MO, and NV. O.U.S.: None
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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