FDA Medical devices recall ·
BEAR Implant recall
- Recall number
- Z-1220-2026
- Date
- (initiated December 31, 2025)
- Company / brand
- Miach Orthopaedics
69 Milk St Ste 100, Westborough, MA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 284 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
BEAR Implant. Model Number: 1000.
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model Number: 1000. UDI Number: (01)00860002987804(17)260228(10)7011098. Lot Number: 7011098. Expiration Date: 02/28/2026.
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.
States: Alaska California Colorado Connecticut Florida Georgia Illinois Massachusetts Maryland Maine Michigan Minnesota Missouri North Carolina New Jersey New York Ohio Oregon Texas Virginia Washington Wisconsin
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1220-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.