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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Implants & Prosthetics

BEAR Implant Recalled for Distribution Errors

Agency Publication Date: November 7, 2025
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Summary

Miach Orthopaedics has recalled 167 units of the BEAR Implant (Bridge-Enhanced ACL Restoration), Model 1000. The recall affects lot number 7008409, which was distributed through sales force trunk stock. No injuries have been reported in connection with this distribution error, which occurred in February 2023.

Risk

The recall was initiated due to distribution errors involving sales force trunk stock. While no injuries have been reported, improper tracking or handling of surgical implants can pose a risk to patient safety. If you are a patient with this implant, contact your surgeon or healthcare provider to discuss your treatment plan.

What You Should Do

  1. This recall affects the BEAR Implant (Bridge-Enhanced ACL Restoration), Model 1000, specifically from lot number 7008409 (UDI-DI 00860002987804).
  2. Healthcare facilities and surgeons should identify any remaining stock from the affected lot by checking the packaging label or surgical inventory records.
  3. Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.
  4. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional information regarding medical device recalls.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: BEAR Implant (Bridge-Enhanced ACL Restoration)
Model / REF:
1000
Lot Numbers:
7008409
UDI:
00860002987804

Field action was limited to the affected lot from sales force trunk stock only.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97742
Status: Active
Manufacturer: Miach Orthopaedics
Sold By: Sales force trunk stock
Manufactured In: United States
Units Affected: 167 units
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.