Quick Facts at a Glance
- Recall Date
- December 31, 2025
- Hazard Level
- HIGH
- Brand
- Miach Orthopaedics
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Miach Orthopaedics
- Product type
- Implant
- Model numbers
- Model Number: 1000. UDI Number: (01)00860002987804(17)260228(10)7011098. Lot Number: 7011098. Expiration Date: 02/28/2026.
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
December 31, 2025
Reported by FDA DEVICE
February 4, 2026
RecallRadar source check
February 11, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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 You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Miach Orthopaedics or your healthcare provider for instructions. Notification method: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
About This Product
The BEAR Implant is a medical device used in orthopedic procedures. Patients rely on its effectiveness for healing and recovery.
Why This Is Dangerous
The incorrect expiration date on the label means that the product may not be safe or effective beyond the labeled date. This can lead to serious health risks if used past its intended shelf life.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients who have received this implant may face health risks if they continue to use it. The recall necessitates immediate action to ensure patient safety.
Practical Guidance
How to identify if yours is affected
- Check the product label for the model number.
- Verify the expiration date listed on the label.
- Contact Miach Orthopaedics if unsure about the product's status.
Where to find product info
The model number and expiration date can typically be found on the label attached to the product packaging.
What timeline to expect
Expect a refund or replacement processing time of 4-6 weeks.
If the manufacturer is unresponsive
- Document all communication attempts with the manufacturer.
- Reach out to healthcare providers for assistance.
- Consider filing a complaint with relevant health authorities if unresponsive.
How to prevent similar issues
- Always check expiration dates on medical devices before use.
- Keep records of all medical devices received for easy reference during recalls.
- Follow manufacturer guidelines for device usage.
Documentation advice
Keep copies of receipts, notices from the manufacturer, and any correspondence regarding the recall for your records.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
The recalled product is the BEAR Implant, Model Number 1000. The UDI Number is (01)00860002987804(17)260228(10)7011098. It was sold nationwide in the US.
Key Facts
- Quantity recalled: 284 units
- Classification: Class II
- Hazard level: High
- Affected states: AK, CA, CO, CT, FL, GA, IL, MA, MD, ME, MI, MN, MO, NC, NJ, NY, OH, OR, TX, VA, WA,
- Expiration date of affected products: 02/28/2026
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.
