ET III Nano-HA fixture System ET NH Dental Implant Model # ET3R5010B -Intended for Dental Implant Catalog #: AET3R5010B
FDA device recall Z-1604-2023 · posted 2023-05-18 · Open, Classified
Recall details
- Recalling firm
- Hiossen Inc.
- 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
- Action taken
- 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
- Root cause
- Labeling Change Control
- Status
- Open, Classified
- Product code
- DZE
- Quantity affected
- 287 units
- Distribution
- US Nationwide Distribution
- Date initiated
- 2023-04-06
- Date posted
- 2023-05-18
- Location
- Fairless Hills, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ET III Bio-SA Fixture System (K151626) | Hiossen, Inc. | 2016-07-21 |