Device product
GM Helix Acqua Implant, Article Number: 140.984
Z-1862-2025
Product summary
- Event
- Event 96806
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 300 units (125 US, 175 OUS)
- Official record key
device-enforcement:Z-1862-2025
Official wording
Reason: It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.
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.
Derived failure modes
-
Unknown
It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.