BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-1604-2023 · Initiated April 6, 2023

    Recall

    Recall Number
    Z-1604-2023
    Event Number
    92272
    Firm
    Hiossen Inc. Keystone Industrial Port Complex
    FEI Number
    3007135442
    Product Code
    DZE
    Status
    Open, Classified
    Root Cause
    Labeling Change Control
    Initiated
    April 6, 2023
    Posted
    May 18, 2023
    Address
    85 Ben Fairless Dr, Fairless Hills, PA, 19030-5012

    Description

    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

    Action

    Hoissen Inc. initial contact verbally through sales rep. on April 7, 2023 and by "URGENT: MEDICAL DEVICE RECALL" Letter via Mail & email on 04/19/2023. Letter states reason for recall, health risk and action to take: 1. Do not use the Recall Implants. 2. Quarantine (separate) the Recall Implants in a different location, away from normal stock room. 3. Immediately fill out the Acknowledgement and Receipt Form* (Fax: 267-795-7031 or Email: [email protected]) *Response is required regardless if the Recall Implants have already been return or implanted. 4. Returned the Recall Implant(s) as Unusable Returns to Hiossen QA** **Contact your sales representative for assistance. 5. Replacement devices are available for delivery. If you need any further information or support concerning this recall/issue, please reach HIOSSEN: Monday through Friday, 8:00 AM to 4:30 PM, Eastern Time. Tel: 267-795-7031 Email: [email protected]

    Distribution

    US Nationwide Distribution

    Quantity

    287 units