Orthofix U.S. LLC recalled 14,201 units of the Forza Ti Spacer System on November 3, 2025. The recall stems from inconsistent labeling claims that may mislead users. Patients and healthcare providers should stop using the product immediately and follow recall instructions.
Labeling contains claims that are not consistently present.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Orthofix U.S. LLC or your healthcare provider for instructions. Notification method: E-Mail
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The Forza Ti Spacer System is a medical device used in orthopedic procedures to provide structural support. Consumers buy this product for its intended use in surgeries and rehabilitation.
The labeling inconsistencies can lead to incorrect use of the device, which may affect patient outcomes. Accurate labeling is critical in the medical field to ensure safety and efficacy.
This recall is not part of a broader industry pattern.
Consumers may face health risks if they rely on misleading information from the product's labeling. Immediate action is necessary to mitigate the risks associated with this recall.
Product information can typically be found on the packaging or the device itself, often near the barcode or on a label.
Expect a timeline of 4-6 weeks for refund processing after the company receives your request.
Keep a copy of your purchase receipt, any correspondence with the manufacturer, and photographs of the product for your records.
The recalled Forza Ti Spacer System includes multiple models with catalog numbers ranging from 38-2006SP to 38-3414SP. The products were distributed worldwide, including across all U.S. states and several countries like Australia, Germany, and Canada. The quantity recalled is 14,201 units.
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