ET III Nano-HA fixture System ET NH Dental Implant Model # ET3R5010B -Intended for Dental Implant Catalog #: AET3R5010B
This recall is currently active, issued May 18, 2023. It was issued by Hiossen Inc. Keystone Industrial Port Complex.
- Recall Initiated
- April 6, 2023
- Posted
- May 18, 2023
- Recall Number
- Z-1604-2023
- Quantity
- 287 units
- Firm Location
- Fairless Hills, PA
- Official Source
- View on FDA website ↗
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
Distribution
US Nationwide Distribution
Lot / Code Info
UDI-DI: 00814913023717 Lot Number: H1E22J263
Root Cause
Labeling Change Control
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