[pending] GM Helix Acqua Implant, Article Number: 140.985
Pending LLM rewrite. Source: FDA_DEVICE Z-1863-2025.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.
The recalled product
- Product
- GM Helix Acqua Implant, Article Number: 140.985
- Manufacturer
- Straumann USA LLC
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Article Number: 140.985
- UDI-DI: (01)7899878024569(11)220125(17)270124(10)JPZ75
- Lot number: JPZ75
Distribution
Distributed nationwide across the United States.
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