Z-0513-2022 Class II Terminated
FDA device recall Z-0513-2022 was initiated by Straumann USA LLC on November 30, 2021 and is designated Class II. Reason for recall: 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… The recall status is terminated (terminated February 5, 2025). Affected quantity: 1 unit.
Recall Details
- Product Type
- Devices
- Report Date
- January 26, 2022
- Initiation Date
- November 30, 2021
- Termination Date
- February 5, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 unit
Product Description
Neodent Easypack Helix GM Acqua 3.5X13/Smart 4.5X2.5 Article Number: 138.107
Reason for Recall
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
Distribution Pattern
US Nationwide Distribution in the states of FL, IL, OH
Code Information
Lot GNV20: UDI:7899878052906