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U.S. Department of Health and Human Services

Class 2 Device Recall Hiossen

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  Class 2 Device Recall Hiossen see related information
Date Initiated by Firm April 06, 2023
Date Posted May 18, 2023
Recall Status1 Open3, Classified
Recall Number Z-1604-2023
Recall Event ID 92272
510(K)Number K151626  
Product Classification Implant, endosseous, root-form - Product Code DZE
Product ET III Nano-HA fixture System ET NH Dental Implant Model # ET3R5010B -Intended for Dental Implant
Catalog #: AET3R5010B
Code Information UDI-DI: 00814913023717 Lot Number: H1E22J263
Recalling Firm/
Manufacturer		 Hiossen Inc.
Keystone Industrial Port Complex
85 Ben Fairless Dr
Fairless Hills PA 19030-5012
For Additional Information Contact SAME
267-759-7081
Manufacturer Reason
for Recall		 Mis-labeled length of the dental implant on the Recall Implant's package. Dental implant size D5.0 x L8.5mm, labeled as D5.0 x L10mm
FDA Determined
Cause 2		 Labeling Change Control
Action Hoissen Inc. initial contact verbally through sales rep. on April 7, 2023 and by "URGENT: MEDICAL DEVICE RECALL" Letter via Mail & email on 04/19/2023. Letter states reason for recall, health risk and action to take: 1. Do not use the Recall Implants. 2. Quarantine (separate) the Recall Implants 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 Recall Implants have already been return or implanted. 4. Returned the Recall Implant(s) as Unusable Returns to Hiossen QA** **Contact your sales representative for assistance. 5. Replacement devices are available for delivery. 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.com
Quantity in Commerce 287 units
Distribution US Nationwide Distribution
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = DZE and Original Applicant = HiOSSEN Inc.
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