Z-1604-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- May 24, 2023
- Initiation Date
- April 6, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 287 units
Product Description
ET III Nano-HA fixture System ET NH Dental Implant Model # ET3R5010B -Intended for Dental Implant Catalog #: AET3R5010B
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 Pattern
US Nationwide Distribution
Code Information
UDI-DI: 00814913023717 Lot Number: H1E22J263