9006767 Astra EV 4.8mm Milled Titanium Abutment Milled abutments are too be used in conjunction with an endosseous de
Summary
The FDA issued a Class II for 9006767 Astra EV 4.8mm Milled Titanium Abutment Milled abutments are too be u by Preat Corp. Reason: Due to incorrect milled titanium abutment being packaged and labeled..
Details
Source
Device Recall
External ID
Z-2318-2024
Action Date
2024-07-17
Status
Ongoing
Category
device
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.
Lot/Code Info: Model Number: 9006767 UDI-DI code: 00842092159477 Lot Numbers: ED11-20247825, ED11-20248895, ED11-20249165 and 241588
Quantity Affected: 7 abutmens
Reason for Recall
Due to incorrect milled titanium abutment being packaged and labeled.
Distribution
U.S.: CA, MO, and NV. O.U.S.: None
Type: Voluntary: Firm initiated
Recall Initiated: 2024-04-10
Company
Santa Maria, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 188 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Preat Corp has 11 FDA actions in our database, including 11 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Preat Corp) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Preat Corp have FDA actions?
Preat Corp has 11 FDA actions in our database, including 11 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2318-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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