Orthofix U.S. LLC has recalled 20 units of the Pillar SA Ti Spacer System, a sterile titanium alloy spinal fusion implant. The external packaging is incorrectly labeled with a 10mm height, even though the actual device is 10.5mm tall. While the implant and its corresponding trial tool are correctly laser-marked with the 10.5mm height, the mislabeled box could lead to surgical errors. There have been no reports of injuries or incidents related to this labeling issue.
A 0.5mm discrepancy in height could cause a surgeon to select the wrong implant size based on the outer label. This may lead to surgical delays or improper fit of the device within the patient's spine if the error is not identified by checking the markings on the device itself before implantation.
Mislabeled as 10mm height; actual height is 10.5mm.
Mislabeled as 10mm height; actual height is 10.5mm.
Mislabeled as 10mm height; actual height is 10.5mm.
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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