Z-3173-2026 Class II Ongoing
FDA device recall Z-3173-2026 was initiated by Straumann USA LLC on August 12, 2026 and is designated Class II. Reason for recall: There is a discrepancy between the product identification on the packaging and the dimensions of the implant contained inside. The recall status is ongoing. Affected quantity: 216.
Recall Details
- Product Type
- Devices
- Report Date
- September 23, 2026
- Initiation Date
- August 12, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 216
Product Description
GM Helix Implant, REF: 109.984;
Reason for Recall
There is a discrepancy between the product identification on the packaging and the dimensions of the implant contained inside.
Distribution Pattern
US Nationwide distribution in the states of AL, AZ, CA, CO, FL, GA, IL, KS, LA, MA, MI, MO, NC, NJ, NV, NY, OH, OK, OR, PA, SC, TX, VA, WI;
Code Information
REF: 109.984; UDI: (01)7899878024552(11)251122(17)301121(10)VZPF4; Lot: VZPF4;