[pending] BEAR Implant. Model Number: 1000.
Pending LLM rewrite. Source: FDA_DEVICE Z-1220-2026.
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
Incorrect expiration date on label that extends beyond the product's documented/approved shelf life. With an incorrect expiration date, the UDI will also be incorrect.
The recalled product
- Product
- BEAR Implant. Model Number: 1000.
- Manufacturer
- Miach Orthopaedics
- Category
- Medical Device — Devices
Distribution
Distributed nationwide across the United States.
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