Recall Z-2318-2024— Preat Corp

Name: FDA recall Z-2318-2024
Creator: U.S. Food and Drug Administration
Published: 2024-04-10

Class II · Ongoing

Class II FDA medical device recall by Preat Corp, initiated 2024-04-10. It names one FDA 510(k) clearance: K220823. 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.. Reason: Due to incorrect milled titanium abutment being packaged and labeled..

Recalling firm: Preat Corp
Classification: Class II
Status: Ongoing
Initiated: 2024-04-10
Firm location: Santa Maria, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K220823 — Preat AbutmentsPreat Corporation·cleared 2022-10-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

Due to incorrect milled titanium abutment being packaged and labeled.

Data sourced from openFDA. This site is unofficial and independent of the FDA.