| Date Initiated by Firm | April 06, 2023 |
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| Date Posted | May 18, 2023 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1604-2023 |
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| Recall Event ID |
92272 |
| 510(K)Number | K151626 |
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| 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 |
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FDA Determined
Cause 2 | Labeling Change Control |
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| 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 |
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| Quantity in Commerce | 287 units |
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| Distribution | US Nationwide Distribution |
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| Total Product Life Cycle | TPLC Device Report |
|---|
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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.
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| 510(K) Database | 510(K)s with Product Code = DZE
|
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