Z-1862-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- June 4, 2025
- Initiation Date
- May 1, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 300 units (125 US, 175 OUS)
Product Description
GM Helix Acqua Implant, Article Number: 140.984
Reason for Recall
It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.
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.
Code Information
Article Number: 140.984; UDI-DI: (01)7899878025290(11)220122(17)260121(10)JPZ21; Lot number: JPZ21;