Class II — Miach Orthopaedics
| Recalling firm | Miach Orthopaedics |
|---|---|
| Registered facility | MIACH ORTHOPAEDICS (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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. |
| Product | BEAR Implant. Model Number: 1000. |
| Quantity | 284 units |
| Distribution | US Nationwide distribution in the states of AK, CA, CO, CT, FL, GA, IL, MA, MD, ME, MI, MN, MO, NC, NJ, NY, OH, OR, TX, VA, WA, WI. |
| Initiated | 2025-12-31 |
| Classified | 2026-01-29 |
| Recall number | Z-1220-2026 |
| 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-1220-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/98280/
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