ET III Nano-HA fixture System ET NH Dental Implant Model # ET3R5010B -Intended for Dental Implant Catalog #: AET3R5010B
Summary
The FDA issued a Class II for ET III Nano-HA fixture System ET NH Dental Implant Model # ET3R5010B -Intended f by Hiossen Inc.. Reason: Mis-labeled length of the dental implant on the Recall Implant's package. Dental implant size D5.0 x L8.5mm, labeled as D5.0 x L10mm.
Details
Source
Device Recall
External ID
Z-1604-2023
Action Date
2023-05-24
Status
Ongoing
Category
device
Product Description
ET III Nano-HA fixture System ET NH Dental Implant Model # ET3R5010B -Intended for Dental Implant Catalog #: AET3R5010B
Lot/Code Info: UDI-DI: 00814913023717 Lot Number: H1E22J263
Quantity Affected: 287 units
Reason for Recall
Mis-labeled length of the dental implant on the Recall Implant's package. Dental implant size D5.0 x L8.5mm, labeled as D5.0 x L10mm
Distribution
US Nationwide Distribution
Type: Voluntary: Firm initiated
Recall Initiated: 2023-04-06
Company
Fairless Hills, PA
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 147 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Hiossen Inc. has 13 FDA actions in our database, including 7 recalls and 6 clearances.
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 (Hiossen Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Hiossen Inc. have FDA actions?
Hiossen Inc. has 13 FDA actions in our database, including 7 recalls and 6 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1604-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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