Drug recall
GM Helix Acqua Implant, Article Number: 140.984
FDA recall event 96806 · Class II · Straumann USA LLC
Key facts
| Event ID | 96806 |
|---|---|
| Recall numbers | Z-1862-2025, Z-1863-2025 |
| Recalling firm | Straumann USA LLC |
| Product type | Devices |
| Products | GM Helix Acqua Implant, Article Number: 140.984, GM Helix Acqua Implant, Article Number: 140.985 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead. |
| Initiation date | May 1, 2025 |
| Report date | Jun 4, 2025 |
| City | Andover |
| State | MA |
| Country | United States |
| FEI number | 1000121052 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: