Orthofix U.S. recalled 34,582 units of its FORZA PTC Spacer System on November 3, 2025, due to inconsistent labeling claims. The recall affects multiple models sold worldwide, including the U.S. and several countries. Consumers and healthcare providers should stop using the product immediately.
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 models include 38-1007SP through 38-9014SP. The products were distributed worldwide, including in all U.S. states and various countries such as Canada and Germany. The devices range in dimensions, with various widths and heights.
The recall stems from labeling that contains claims not consistently present. This inconsistency poses potential risks to patients relying on accurate information for safe use.
There are no reported incidents or injuries related to this recall at this time. Consumers are urged to take the recall seriously due to the potential for harm.
Stop using the FORZA PTC Spacer System immediately. Contact Orthofix U.S. LLC or your healthcare provider for further instructions. Follow the recall instructions provided by the manufacturer.
For more information, consumers can visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0892-2026.
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