Official recall notice
FDA DeviceClass IINotable
FDA Recall: GM Helix Implant, REF: 109.984;
- Recall date
- 2026-09-23
- Brand
- Straumann USA LLC
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
There is a discrepancy between the product identification on the packaging and the dimensions of the implant contained inside.
Product description
There is a discrepancy between the product identification on the packaging and the dimensions of the implant contained inside.
Affected products
REF: 109.984; UDI: (01)7899878024552(11)251122(17)301121(10)VZPF4; Lot: VZPF4;