medical Class II Updated 2022-01-26

Straumann USA LLC recalls Neodent Easypack Helix GM Acqua 3.5X13/Smart 4.5X2.5 Articl

Recalled Product

Neodent Easypack Helix GM Acqua 3.5X13/Smart 4.5X2.5 Article Number: 138.107

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot GNV20: UDI:7899878052906
View official government recall

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