Recall Z-1276-2025 ยท NHA Abutment, Implant, Dental, Endosseous
Hiossen Inc.
Osstem Implant System - Abutment: ET Multi AbutmentSize: 4.8D 5.0GH - Abutment is intended for use with a dental implant to provide suport for prosthetic restorations such as crowns, bridges, or overdentures. Model/Catalog Number: ETMTA505RV1
| Date | Mar 5, 2025 (initiated Jan 27, 2025) |
| Status | Open, Classified |
| 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 addr |
| Quantity | 119 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K161689 | OSSTEM Implant System - Abutment Osstem Implant Co., Ltd., May 22, 2017 |