FDA-Device2023-05-24Class II
ET III Nano-HA fixture System ET NH Dental Implant Model # ET3R5010B -Intended for Dental Implant Catalog #: AET3R5010B
Hiossen Inc.
Hazard
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
Sold states
US Nationwide Distribution
Affected count
287 units
Manufactured in
Keystone Industrial Port Complex, 85 Ben Fairless Dr, Fairless Hills, PA, United States
Products
ET III Nano-HA fixture System ET NH Dental Implant Model # ET3R5010B -Intended for Dental Implant Catalog #: AET3R5010B
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1604-2023Don't want to check this manually?
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