Z-1862-2025 Class II Ongoing
FDA device recall Z-1862-2025 was initiated by Straumann USA LLC on May 1, 2025 and is designated Class II. Reason for recall: It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead. The recall status is ongoing. Affected quantity: 300 units (125 US, 175 OUS).
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;