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Miach Orthopaedics: BEAR Implant. Model Number: 1000.

Medical DevicesSource: FDA (device) · Date: 2026-02-04

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Miach Orthopaedics
Product
BEAR Implant. Model Number: 1000.
Reason / hazard
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.
Classification
Class II
Status
Ongoing
Distribution / sold at
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.
Recall initiated
2025-12-31
Code info
Model Number: 1000. UDI Number: (01)00860002987804(17)260228(10)7011098. Lot Number: 7011098. Expiration Date: 02/28/2026.
Product quantity
284 units
Voluntary mandated
Voluntary: Firm initiated
City
Westborough
State
MA
Country
United States
Event id
98280
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