Device product
ET III Nano-HA fixture System ET NH Dental Implant Model # ET3R5010B -Intended for Dental Implant Catalog #: AET3R5010B
Z-1604-2023
Product summary
- Firm
- Hiossen Inc.
- Event
- Event 92272
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 287 units
- Official record key
device-enforcement:Z-1604-2023
Official wording
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
Code information: UDI-DI: 00814913023717 Lot Number: H1E22J263
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Unknown
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