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 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.
The recall is due to labeling claims that are not consistently present, which poses a risk to users. Misleading information on medical devices can lead to improper use or reliance on the product, potentially compromising patient health.
As of the recall date, there were no reported injuries or adverse events directly linked to the labeling issues. However, the potential for misunderstanding the product's use remains a concern.
Stop using the Forza Ti Spacer System immediately. Contact Orthofix U.S. LLC or your healthcare provider for further instructions and follow the recall guidance provided. Refund processes may vary.
For more information, contact Orthofix U.S. LLC at [insert contact number] or visit their website for detailed recall instructions.
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