FDA Medical devices recall ·
Osstem Implant System - Abutment ET Multi Abutment Size: 4.8D 3.0G/H-… recall
- Recall number
- Z-1274-2025
- Date
- (initiated January 27, 2025)
- Company / brand
- Hiossen Inc.
85 Ben Fairless Dr, Fairless Hills, PA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 19 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
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
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot Code: UDI-DI: 00810019241529 Lot# H4E21D092
Distribution
US Nationwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1274-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.