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Recall Observatory FDA recall evidence

Device 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.

Z-2318-2024

April 10, 2024

Class II

Product summary

Firm
Preat Corp
Event
Event 94693
Status
Ongoing
Classification
Class II
Quantity
7 abutmens
Official record key
device-enforcement:Z-2318-2024

Official wording

Reason: Due to incorrect milled titanium abutment being packaged and labeled.

Code information: Model Number: 9006767 UDI-DI code: 00842092159477 Lot Numbers: ED11-20247825, ED11-20248895, ED11-20249165 and 241588

Distribution pattern: U.S.: CA, MO, and NV. O.U.S.: None

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Due to incorrect milled titanium abutment being packaged and labeled.