Recall Z-1604-2023 ยท DZE Implant, Endosseous, Root-Form
Hiossen Inc.
ET III Nano-HA fixture System ET NH Dental Implant Model # ET3R5010B -Intended for Dental Implant Catalog #: AET3R5010B
| Date | May 18, 2023 (initiated Apr 6, 2023) |
| Status | Open, Classified |
| Reason | 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 |
| Root cause | 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 Unusa |
| Quantity | 287 units |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151626 | ET III Bio-SA Fixture System Hiossen, Inc., Jul 21, 2016 |