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FDA (Device enforcement)Recalled 2025-12-31class ii

Miach Orthopaedics: BEAR Implant. Model Number: 1000.

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.

Details from the source

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. 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. Quantity: 284 units Lot/code info: Model Number: 1000. UDI Number: (01)00860002987804(17)260228(10)7011098. Lot Number: 7011098. Expiration Date: 02/28/2026.

UPC codes

00860002987804

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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