PlainRecalls
FDA Devices Moderate Class II Ongoing

BEAR Implant. Model Number: 1000.

Reported: February 4, 2026 Initiated: December 31, 2025 #Z-1220-2026

Product Description

BEAR Implant. Model Number: 1000.

Reason for Recall

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.

Details

Recalling Firm
Miach Orthopaedics
Units Affected
284 units
Distribution
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.
Location
Westborough, MA

Frequently Asked Questions

What product was recalled?
BEAR Implant. Model Number: 1000.. Recalled by Miach Orthopaedics. Units affected: 284 units.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on February 4, 2026. Severity: Moderate. Recall number: Z-1220-2026.