FDA Device recall Z-3173-2026
GM Helix Implant, REF: 109.984
- FDA Device
- Class II
- ongoing
- Published 2026-09-23
On 2026-09-23 the FDA classified a Class II recall of GM Helix Implant, REF: 109.984 by Straumann Usa, citing there is a discrepancy between the product identification on the packaging and the dimensions of the implant contained inside.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3173-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-08-12 |
| Published | 2026-09-23 |
| Last updated | 2026-09-29 05:30 UTC |
| Company | Straumann Usa |
| Distribution | US |
Product
GM Helix Implant, REF: 109.984;
Reason
There is a discrepancy between the product identification on the packaging and the dimensions of the implant contained inside.
Identifiers
| code_info | REF: 109.984; UDI: (01)7899878024552(11)251122(17)301121(10)VZPF4; Lot: VZPF4; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-29 05:30 UTC. Current status: ongoing.
Other recalls by Straumann Usa
- GM Helix Implant, Endosseous Dental Implant Article No. 109.984
FDA Device · Class II · 2026-08-19 · Straumann Usa - Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim (Article 021.5314)
FDA Device · Class II · 2026-08-19 · Straumann Usa - Straumann n!ce Zr, HT, Full-arch Restoration
FDA Device · Class II · 2026-05-06 · Straumann Usa - Straumann n!ce PMMA Full-arch Restoration
FDA Device · Class II · 2026-05-06 · Straumann Usa - Custom Abutment AS Ti, for Straumann RC, incl
FDA Device · Class II · 2026-04-01 · Straumann Usa
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3173-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.