Straumann USA LLC: Medical Device Recall in 2022 - (Recall #: Z-0513-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 30, 2021

Date Posted: January 26, 2022

Recall Number: Z-0513-2022

Event ID: 89321

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

Status: Terminated

Product Quantity: 1 unit

Code Information:

Lot GNV20: UDI:7899878052906

Distribution Pattern:

US Nationwide Distribution in the states of FL, IL, OH

Voluntary or Mandated:

Voluntary: Firm initiated