Straumann USA LLC: Medical Device Recall in 2025 - (Recall #: Z-1862-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

GM Helix Acqua Implant, Article Number: 140.984

Product Classification:

Class II

Date Initiated: May 1, 2025

Date Posted: June 4, 2025

Recall Number: Z-1862-2025

Event ID: 96806

Reason for Recall:

It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.

Status: Ongoing

Product Quantity: 300 units (125 US, 175 OUS)

Code Information:

Article Number: 140.984; UDI-DI: (01)7899878025290(11)220122(17)260121(10)JPZ21; Lot number: JPZ21;

Distribution Pattern:

Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, Il KS, LA, MA, MD, MI, NE, NH, NJ, NY, OH, OK, RI, SC, TN, TX, UT, WI and the countries of Australia, Croatia, France, Hungary, India, Italy, Lebanon, Lithuania, New Zealand, Portugal, Qatar, Serbia, Spain, Tunisia, UAE, United Kingdom, Vietnam.

Voluntary or Mandated:

Voluntary: Firm initiated