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U.S. Department of Health and Human Services

Class 2 Device Recall ET PROSTHETIC SYSTEM

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 Class 2 Device Recall ET PROSTHETIC SYSTEMsee related information
Date Initiated by FirmJanuary 27, 2025
Date PostedMarch 05, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1273-2025
Recall Event ID 96178
510(K)NumberK130662 
Product Classification Abutment, implant, dental, endosseous - Product Code NHA
ProductET 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
Code Information Lot Code: UDI-DI: 00814913026336 Lot# H4E20L090
Recalling Firm/
Manufacturer		 Hiossen Inc.
85 Ben Fairless Dr
Fairless Hills PA 19030-5012
For Additional Information ContactMateusz Leszczak
201-2660657
Manufacturer 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
FDA Determined
Cause 2		Under Investigation by firm
ActionHoissen 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 in Commerce16 units
DistributionUS Nationwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = NHA
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