Orthofix U.S. recalled three intervertebral body fusion devices on June 24, 2025. A labeling error states the width as 33 mm instead of the correct 37 mm. Patients and healthcare providers must stop using the device immediately.
A 37 mm implant width intervertebral body fusion device has a labeling discrepancy with incorrect width of 33 mm stated on the outer label side flap and inner label side flap information box. The 37 mm width on the front labels is correct.
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: Letter
The recalled product is the PILLAR SA Ti, sterile, with dimensions of 37mm (W) x 28mm (D) x 18mm (H). It was distributed nationwide in the U.S., particularly in Colorado and California.
The device has a labeling discrepancy that could lead to improper use. The outer label states an incorrect width of 33 mm, potentially causing complications during procedures.
No injuries or incidents have been reported due to this labeling issue. The recall affects a total of three devices.
Patients and healthcare providers should stop using the affected devices immediately. Contact Orthofix U.S. LLC or your healthcare provider for further instructions.
For more information, call Orthofix U.S. LLC or visit their website. Additional details are available at the FDA recall notice.
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