GM Helix Implant — Class II medical device recall Z-2929-2026
Ongoing recall by Straumann USA LLC, reported 2026-08-19, distributed nationwide. There may be a mismatch between the implant contained inside the packaging and the information described on th
| Recall number | Z-2929-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Straumann USA LLC, Andover, MA, United States |
| Recall initiated | 2026-07-13 |
| Classified | 2026-08-10 |
| Reported by FDA | 2026-08-19 |
| Distributed | Nationwide (US) |
| Quantity | 417 us |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 07899878024552 |
| Lot numbers | MVXJ9 |
Product
GM Helix Implant, Endosseous Dental Implant Article No. 109.984
Reason for recall
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2929-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.