FDA recall Z-1863-2025

Product

GM Helix Acqua Implant, Article Number: 140.985

Reason for recall

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

Distribution

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.

Key facts

Status

Ongoing

Initiation date

2025-05-01

Report date

2025-06-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Andover, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1863-2025