Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0513-2022 — Neodent Easypack Helix GM Acqua 3.5X13/Smart 4.5X2.5 Article Number: 138.107

U.S. FDA — Device Enforcement · United States · 2021-11-30 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0513-2022
Date of alert
2021-11-30
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Straumann USA LLC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
7899878052906
Reported risk: 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
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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