Recall Z-1604-2023— Hiossen Inc.

Name: FDA recall Z-1604-2023
Creator: U.S. Food and Drug Administration
Published: 2023-04-06

Class II · Ongoing

Class II FDA medical device recall by Hiossen Inc., initiated 2023-04-06. It names one FDA 510(k) clearance: K151626. Product: ET III Nano-HA fixture System ET NH Dental Implant Model # ET3R5010B -Intended for Dental Implant Catalog #: AET3R5010B. 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.

Recalling firm: Hiossen Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-04-06
Firm location: Fairless Hills, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K151626 — ET III Bio-SA Fixture SystemHiossen, Inc.·cleared 2016-07-21

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

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

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