FDA Medical devices recall ·
GM Helix Acqua Implant, Article Number: 140.984 recall
- Recall number
- Z-1862-2025
- Date
- (initiated May 1, 2025)
- Company / brand
- Straumann USA LLC
60 Minuteman Rd, Andover, MA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 300 units (125 US, 175 OUS)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
GM Helix Acqua Implant, Article Number: 140.984
Why was it recalled?
It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Article Number: 140.984; UDI-DI: (01)7899878025290(11)220122(17)260121(10)JPZ21; Lot number: JPZ21;
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.
States: Arizona California Colorado Florida Georgia Kansas Louisiana Massachusetts Maryland Michigan Nebraska New Hampshire New Jersey New York Ohio Oklahoma Rhode Island South Carolina Tennessee Texas Utah Wisconsin
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1862-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.