FDA Device recall Z-2929-2026
GM Helix Implant, Endosseous Dental Implant Article No. 109.984
- FDA Device
- Class II
- ongoing
- Published 2026-08-19
On 2026-08-19 the FDA classified a Class II recall of GM Helix Implant, Endosseous Dental Implant Article No. 109.984 by Straumann Usa, citing there may be a mismatch between the implant contained inside the packaging and the information described on the outer carton label. If the the incorrect implant is installed, the….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2929-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-07-13 |
| Published | 2026-08-19 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Straumann Usa |
| Distribution | US |
Product
GM Helix Implant, Endosseous Dental Implant Article No. 109.984
Reason
There may be a mismatch between the implant contained inside the packaging and the information described on the outer carton label. If the the incorrect implant is installed, the issue could cause bone compression or difficulty during installation in situations where there is sufficient bone volume
Identifiers
| code_info | UDI-DI 7899878024552 Lot MVXJ9 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2929-2026%22
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