[pending] BEAR Implant (Bridge-Enhanced ACL Restoration); Model/Catalog: 1000;
Pending LLM rewrite. Source: FDA_DEVICE Z-0479-2026.
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
The field action was initiated in February of 2023 and was limited to the affected lot from sales force trunk stock only.
The recalled product
- Product
- BEAR Implant (Bridge-Enhanced ACL Restoration); Model/Catalog: 1000;
- Manufacturer
- Miach Orthopaedics
- 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)
- Model/Catalog: 1000
- UDI-DI: 00860002987804
- Lot number: 7008409
Distribution
Distributed nationwide across the United States.
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