FDA recall, , Moderate risk
Miach Orthopaedics BEAR Implant
The BEAR Implant has an incorrect expiration date on its label.
Summary by Recall Canary from the FDA notice
What happened
Miach Orthopaedics, based in Westborough, Massachusetts, recalled the BEAR Implant, Model Number 1000, because the label has an incorrect expiration date that extends beyond the product's documented/approved shelf life, and with an incorrect expiration date, the UDI will also be incorrect. The recall began December 31, 2025, and was added to the FDA's Enforcement Report on January 29, 2026.
The product was distributed nationwide in the United States, including states such as Alaska, California, Colorado, Connecticut, Florida, Georgia, Illinois, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Texas, Virginia, Washington and Wisconsin. A total of 284 units were involved.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the model number, UDI-DI and lot code listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
BEAR Implant.
- Model
- 1000
- UDI-DI
- 00860002987804
- Lot code
- 7011098
Recall details
- Company began the recall
- Sold in
US Nationwide distribution in the states of 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.
- Company
- Miach OrthopaedicsWestborough, Massachusetts
- Hazard
- Labeling error
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98280
- Recall number
- Z-1220-2026
- Quantity recalled
- 284 units
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
