FDA Medical Device Recalls (openFDA)
Hiossen Inc.: Osstem Implant System - Abutment ET Multi Abutment Size: 4.8D 3.0G/H- Abutment is intended for use with a dental implant to provide suport for prosthetic restorations such as crowns, bridges, or overdentures. Model/Catalog Number: ETMTA503RV1
- Recall number
- Z-1274-2025
- Recalling firm
- Hiossen Inc.
- Product
- Osstem Implant System - Abutment ET Multi Abutment Size: 4.8D 3.0G/H- Abutment is intended for use with a dental implant to provide suport for prosthetic restorations such as crowns, bridges, or overdentures. Model/Catalog Number: ETMTA503RV1
- Status
- Open, Classified
- Initiated
- 2025-01-27
- Posted
- 2025-03-05
- Terminated
- not on file
- Reason
- Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments as Regular version whereas the actual product is a Mini version; and identify the ET Multi Abutments as Mini version whereas the actual product is a Regular version
- Root cause
- Under Investigation by firm
- Action
- Hoissen issued URGENT: MEDICAL DEVICE RECALL-CORRECTION letter on 1/27/25 via USPS Certified Mail. Letter states reason for recall, health risk and action to take. Immediate Actions to be taken by You, the clinician: 1. Do not use the affected devices 2. Quarantine (separate) the affected devices 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 devices have already been return or implanted 4. Return quarantined devices to the following address or contact your sales representative for assistance. ATTN: Peter Lee / Recall 85 Ben Fairless Dr. Fairless Hills, PA 19030 5. Replacement patient chart stickers will be provided so that you may include the corrected chart sticker in the patient s medical records as applicable. Hiossen has already deployed a permanent corrective action to address the issue described in this Recall Notice. Hiossen investigated and identified the source of the issue and has already implemented new procedures which eliminates the potential for further mis-labeling. Other Information 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
- Quantity
- 19 units
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- Lot Code: UDI-DI: 00810019241529 Lot# H4E21D092
- 510(k) numbers
- ["K161689"]
- PMA numbers
- not on file
- Product code
- NHA
- 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