BEAR Implant. Model Number: 1000. recall (Miach Orthopaedics)
Medical deviceClass IIOngoing
Summary: Miach Orthopaedics is recalling BEAR Implant. Model Number: 1000.. Reason: 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 is being recalled
BEAR Implant. Model Number: 1000.
Why
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.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
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. (states named: 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)
How to tell if yours is affected
Model Number: 1000. UDI Number: (01)00860002987804(17)260228(10)7011098. Lot Number: 7011098. Expiration Date: 02/28/2026.
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-1220-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | December 31, 2025 |
| Reported | February 4, 2026 |
| Company | Miach Orthopaedics |
| Company location | Westborough, MA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 284 units |
More recalls from Miach Orthopaedics · all medical device recalls · recalls from December 2025