[pending] Artelon FlexBand Dynamic Matrix Ref: 31057
Pending LLM rewrite. Source: FDA_DEVICE Z-1554-2026.
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
Augmentation devices failed bacterial endotoxin testing.
The recalled product
- Product
- Artelon FlexBand Dynamic Matrix Ref: 31057
- Manufacturer
- International Life Sciences
- 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 (1)
- A10011001/GTIN: 00850003396019
Distribution
Distributed nationwide across the United States.
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