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CLASS II · ModerateFDA

Miach Orthopaedics recalls BEAR Implant.

📅 Dec 31, 2025 · 📍 Nationwide
Recalling company
Miach Orthopaedics
Product
BEAR Implant. Model Number: 1000.
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.
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Dec 31, 2025
Reported
Feb 4, 2026
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.
Status
Ongoing
Quantity
284 units
Lot / codes
Model Number: 1000. UDI Number: (01)00860002987804(17)260228(10)7011098. Lot Number: 7011098. Expiration Date: 02/28/2026.
Company location
Westborough, MA
Recall type
Voluntary: Firm initiated
Recall number
Z-1220-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-1220-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.