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 BEAR Implant is a medical device used in orthopedic procedures. Patients rely on its effectiveness for healing and recovery.
The incorrect expiration date on the label means that the product may not be safe or effective beyond the labeled date. This can lead to serious health risks if used past its intended shelf life.
This recall is not part of a broader industry pattern.
Patients who have received this implant may face health risks if they continue to use it. The recall necessitates immediate action to ensure patient safety.
The model number and expiration date can typically be found on the label attached to the product packaging.
Expect a refund or replacement processing time of 4-6 weeks.
Keep copies of receipts, notices from the manufacturer, and any correspondence regarding the recall for your records.
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.
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