FDA Device recall Z-1863-2025
GM Helix Acqua Implant, Article Number: 140.985
- FDA Device
- Class II
- ongoing
- Published 2025-06-04
On 2025-06-04 the FDA classified a Class II recall of GM Helix Acqua Implant, Article Number: 140.985 by Straumann Usa, citing it is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1863-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-05-01 |
| Published | 2025-06-04 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Straumann Usa |
| Distribution | US |
Product
GM Helix Acqua Implant, Article Number: 140.985
Reason
It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.
Identifiers
| code_info | Article Number: 140.985; UDI-DI: (01)7899878024569(11)220125(17)270124(10)JPZ75; Lot number: JPZ75; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1863-2025%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.