ET Rigid Abutment (Mini) SIze: 4.5D 4.0G/H 4.0H - Intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. Model/Catalog Number: ETRGA4544MP
This recall is currently active, issued March 5, 2025. It was issued by Hiossen Inc..
- Company
- Hiossen Inc.
- Recall Initiated
- January 27, 2025
- Posted
- March 5, 2025
- Recall Number
- Z-1273-2025
- Quantity
- 16 units
- Firm Location
- Fairless Hills, PA
- Official Source
- View on FDA website ↗
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
Distribution
US Nationwide distribution.
Lot / Code Info
Lot Code: UDI-DI: 00814913026336 Lot# H4E20L090
Root Cause
Under Investigation by firm
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