FDA-Device2022-01-26Class II
Neodent Easypack Helix GM Acqua 3.5X13/Smart 4.5X2.5 Article Number: 138.107
Straumann USA LLC
Hazard
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
Sold states
US Nationwide Distribution in the states of FL, IL, OH
Affected count
1 unit
Manufactured in
60 Minuteman Rd, N/A, Andover, MA, United States
Products
Neodent Easypack Helix GM Acqua 3.5X13/Smart 4.5X2.5 Article Number: 138.107
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0513-2022Don't want to check this manually?
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