Orthofix U.S. LLC has recalled three units of the PILLAR SA Ti sterile spinal implants due to a labeling error regarding the device's width. While the front label correctly identifies the implant as 37 mm wide, the side flap and internal label box incorrectly list the width as 33 mm. This discrepancy could cause a surgeon to select the wrong size for a patient, and no injuries have been reported to date.
The incorrect label could lead a healthcare provider to use a size that is inappropriate for the patient's anatomy, which may cause device failure or require additional surgery to correct. Using the wrong size implant during spinal fusion can result in improper stability or patient discomfort.
Quantity: 3 units affected.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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