ET III Nano-HA fixture System ET NH Dental Implant Model # ET3R5010B -Intended for Dental Implant Catalog #: AET3R5010B
FDA Recall Z-1604-2023 · Posted 2023-05-18
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Recalling FirmHiossen Inc.
Recall StatusOpen, Classified
Product CodeDZE
Date Initiated2023-04-06
Product Quantity287 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
Firm 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]
Root Cause
Labeling Change Control
Distribution Pattern
US Nationwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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