FDA recall Z-1604-2023

Hiossen Inc. · Class II · device

Product

ET III Nano-HA fixture System ET NH Dental Implant Model # ET3R5010B -Intended for Dental Implant Catalog #: AET3R5010B

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

Key facts

Status
Ongoing
Initiation date
2023-04-06
Report date
2023-05-24
Voluntary/Mandated
Voluntary: Firm initiated
Location
Fairless Hills, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1604-2023