Class II
Medical Device Recall: BEAR Implant. Model Number: 1000.
Miach Orthopaedics · December 31, 2025
Reason for Recall
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.
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.
States Affected
NATIONWIDE
Quantity Affected
284 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1220-2026
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.