FDA Enforcement
Class II
Ongoing
GM Helix Acqua Implant, Article Number: 140.985
Recall: Z-1863-2025
·
Reported June 4, 2025
Enforcement
- Recall Number
- Z-1863-2025
- Event ID
- 96806
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Straumann USA LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- June 4, 2025
- Initiation Date
- May 1, 2025
- Classification Date
- May 28, 2025
- Address
- 60 Minuteman Rd, N/A, Andover, MA, 01810-1008, United States
Description
GM Helix Acqua Implant, Article Number: 140.985
Reason
It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.
Code Info
Article Number: 140.985; UDI-DI: (01)7899878024569(11)220125(17)270124(10)JPZ75; Lot number: JPZ75;
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.
Quantity
207 units (54 US, 153 OUS)