Straumann USA LLC: Medical Device Recall in 2022 - (Recall #: Z-0512-2022)

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 3.5X8/Smart 4.5X2.5 -intended for dental implant Item 138.089

Product Classification:

Class II

Date Initiated: November 30, 2021

Date Posted: January 26, 2022

Recall Number: Z-0512-2022

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: 7 pieces

Code Information:

Lot GNV17 UDI: 7899878052722

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated