FDAHealthDecember 31, 2025
Miach Orthopaedics — BEAR Implant. Model Number: 1000.
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- December 31, 2025
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.
What's affected?
- Product
- BEAR Implant. Model Number: 1000.
- Brand
- Miach Orthopaedics
- Lot code
- 7011098
Additional details
Model Number: 1000. UDI Number: (01)00860002987804(17)260228(10)7011098. Lot Number: 7011098. Expiration Date: 02/28/2026.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 284 units.
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