Miach Orthopaedics: BEAR Implant. Model Number: 1000.
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Miach Orthopaedics
- Product
- BEAR Implant. Model Number: 1000.
- Reason / hazard
- 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
- Status
- Ongoing
- Distribution / sold at
- 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.
- Recall initiated
- 2025-12-31
- Code info
- Model Number: 1000. UDI Number: (01)00860002987804(17)260228(10)7011098. Lot Number: 7011098. Expiration Date: 02/28/2026.
- Product quantity
- 284 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Westborough
- State
- MA
- Country
- United States
- Event id
- 98280
Free daily digest + "My products" watchlist