Orthofix U.S. LLC has initiated a voluntary recall of 184,464 units of various spinal spacer and fusion systems because the device labeling contains product claims that are not consistently present across all units. The recall affects several product lines, including the CONSTRUX Mini, FORZA PTC, Pillar SA PTC, and FIREBIRD SI Fusion systems. Because the labeling information may be inconsistent, clinical users may not have access to verified claims or instructions required for the proper use of these implants.
Inconsistent labeling on surgical implants can lead to confusion regarding the device's capabilities or specifications, potentially affecting surgical planning or patient outcomes. This recall is classified as low risk, and no specific patient injuries or complications have been reported.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.