Medical device recalls Moderate risk

Miach Orthopaedics recalls BEAR Implant. Model Number: 1000.

Recall date
December 31, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1220-2026
FDA classification
Class II
Brand / firm
Miach Orthopaedics
Sold / distributed
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.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

BEAR Implant. Model Number: 1000.

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