Osstem Implant System - Abutment ET Multi Abutment Size: 4.8D 3.0G/H- Abutment is intended for use with a dental implant
FDA device recall Z-1274-2025 · posted 2025-03-05 · Open, Classified
Recall details
- Recalling firm
- Hiossen Inc.
- Reason for recall
- 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
- Action taken
- 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
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- NHA
- Quantity affected
- 19 units
- Distribution
- US Nationwide distribution.
- Date initiated
- 2025-01-27
- Date posted
- 2025-03-05
- Location
- Fairless Hills, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OSSTEM Implant System - Abutment (K161689) | Osstem Implant Co., Ltd. | 2017-05-22 |