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ET Rigid Abutment recallZ-1273-2025 · Hiossen Inc. · initiated Jan 27, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Hiossen Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was 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

FDA root cause category: Under Investigation by firm

What the company is doing

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: [email protected] ) *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

Recall details

Recall number
Z-1273-2025
Status
Open, Classified
Initiated by the company
Jan 27, 2025
Posted by the FDA
Mar 5, 2025
Recalling firm
Hiossen Inc.
Quantity
16 units
Product code
NHA
FDA submissions
K130662
Distribution
US Nationwide distribution.

Product description

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

Code information (models, lots, serial numbers)

Lot Code: UDI-DI: 00814913026336 Lot# H4E20L090

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

3 devices cleared under K130662 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 96178).

Sources and updates

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