FDA Enforcement
Class II
Terminated
Neodent Easypack Helix GM Acqua 3.5X13/Smart 4.5X2.5 Article Number: 138.107
Recall: Z-0513-2022
·
Reported January 26, 2022
Enforcement
- Recall Number
- Z-0513-2022
- Event ID
- 89321
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Straumann USA LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- January 26, 2022
- Initiation Date
- November 30, 2021
- Classification Date
- January 19, 2022
- Termination Date
- February 5, 2025
- Address
- 60 Minuteman Rd, N/A, Andover, MA, 01810-1008, United States
Description
Neodent Easypack Helix GM Acqua 3.5X13/Smart 4.5X2.5 Article Number: 138.107
Reason
Mislabeled: Carton box item 138.089- Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 has an implant with measure of 3.5x13mm; and Carton Box (138.107- Easypack Helix GM Acqua has a 3.5x8mm implant instead of a 3.5x 13mm implant
Code Info
Lot GNV20: UDI:7899878052906
Distribution
US Nationwide Distribution in the states of FL, IL, OH
Quantity
1 unit