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Recall Observatory FDA recall evidence

Device product

BEAR Implant. Model Number: 1000.

Z-1220-2026

December 31, 2025

Class II

Product summary

Firm
Miach Orthopaedics
Event
Event 98280
Status
Ongoing
Classification
Class II
Quantity
284 units
Official record key
device-enforcement:Z-1220-2026

Official wording

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.

Code information: Model Number: 1000. UDI Number: (01)00860002987804(17)260228(10)7011098. Lot Number: 7011098. Expiration Date: 02/28/2026.

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.