medical Class II Updated 2022-01-26

Straumann USA LLC recalls Neodent Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 -intende

Recalled Product

Neodent Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 -intended for dental implant Item 138.089

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 GNV17 UDI: 7899878052722
View official government recall

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