GM Helix Acqua Implant — Class II medical device recall Z-1862-2025
Ongoing recall by Straumann USA LLC, reported 2025-06-04, distributed nationwide. It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.
| Recall number | Z-1862-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Straumann USA LLC, Andover, MA, United States |
| Recall initiated | 2025-05-01 |
| Classified | 2025-05-28 |
| Reported by FDA | 2025-06-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, ES, FR, GB, HR, HU, IN, IT, LB, LT, NZ, PT, QA, RS, TN, VN |
| UPC / GTIN / UDI-DI | 07899878025290 |
| Lot numbers | JPZ21 |
Product
GM Helix Acqua Implant, Article Number: 140.984
Reason for recall
It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.
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-1862-2025. 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.