FDA Medical Device Recalls (openFDA)
Hiossen Inc.: ET III Nano-HA fixture System ET NH Dental Implant Model # ET3R5010B -Intended for Dental Implant Catalog #: AET3R5010B
- Recall number
- Z-1604-2023
- Recalling firm
- Hiossen Inc.
- Product
- ET III Nano-HA fixture System ET NH Dental Implant Model # ET3R5010B -Intended for Dental Implant Catalog #: AET3R5010B
- Status
- Open, Classified
- Initiated
- 2023-04-06
- Posted
- 2023-05-18
- Terminated
- not on file
- 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
- Root cause
- Labeling Change Control
- 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: recall@hiossen.com) *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: recall@hiossen.com
- Quantity
- 287 units
- Distribution
- US Nationwide Distribution
- Lot, serial or model codes
- UDI-DI: 00814913023717 Lot Number: H1E22J263
- 510(k) numbers
- ["K151626"]
- PMA numbers
- not on file
- Product code
- DZE
- Firm FEI
- 3007135442
- Firm city
- Fairless Hills
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28