Miach Orthopaedics recalled 284 units of the BEAR Implant, Model Number 1000, on December 31, 2025. The recall stems from an incorrect expiration date on the label that exceeds the product's approved shelf life. Patients and healthcare providers should stop using the device immediately and follow recall instructions.
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Miach Orthopaedics or your healthcare provider for instructions. Notification method: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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The recalled product is the BEAR Implant, Model Number 1000. The UDI Number is (01)00860002987804(17)260228(10)7011098. It was sold nationwide in the US.
The BEAR Implant has an incorrect expiration date on its label, extending beyond its documented shelf life. This presents a risk as the expiration date may not accurately reflect the product's safety and effectiveness.
No specific incidents or injuries have been reported at this time. The recall is classified as Class II due to the potential for serious health consequences.
Patients and healthcare providers should stop using the BEAR Implant immediately. Contact Miach Orthopaedics or your healthcare provider for specific instructions on the recall.
For further assistance, contact Miach Orthopaedics through their official website or customer service hotline.
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