Z-1863-2025 Class II Ongoing
FDA device recall Z-1863-2025 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: 207 units (54 US, 153 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
- 207 units (54 US, 153 OUS)
Product Description
GM Helix Acqua Implant, Article Number: 140.985
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: 140.985; UDI-DI: (01)7899878024569(11)220125(17)270124(10)JPZ75; Lot number: JPZ75;