Class II — Miach Orthopaedics
| Recalling firm | Miach Orthopaedics |
|---|---|
| Registered facility | MIACH ORTHOPAEDICS (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | The field action was initiated in February of 2023 and was limited to the affected lot from sales force trunk stock only. |
| Product | BEAR Implant (Bridge-Enhanced ACL Restoration); Model/Catalog: 1000; |
| Quantity | 167 units |
| Distribution | US Nationwide distribution. |
| Initiated | 2023-02-02 |
| Classified | 2025-11-07 |
| Recall number | Z-0479-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Miach Orthopaedics (Z-0479-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97742/
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