Orthofix U.S. recalled 3 Pillar SA Ti intervertebral body fusion devices nationwide in the United States after a labeling discrepancy. The 37 mm implant width is correct on the front label, but the outer side flap and inner label information box incorrectly state 33 mm. Healthcare providers and patients should stop using the device immediately and await manufacturer instructions.
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
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Pillar SA Ti is a sterile spinal interbody fusion device used in fusion surgeries. It measures 37 mm wide, 28 mm deep, and 18 mm tall with a 20-degree angle labeled on the device.
A labeling discrepancy could lead to misinterpretation of device width. The front label shows 37 mm while side labels state 33 mm, which could influence surgical sizing decisions.
This recall is not described as part of a broader industry pattern in the available information.
The recall may cause procedure delays and necessitate device exchanges if incorrect size labeling occurred.
Labels on device packaging and outer side flap; UDI-DI on the packaging
Refund or replacement timelines are not specified; typical recalls process may take 4-8 weeks
Keep the recall notice, packaging, device labels, serial numbers, and hospital correspondence
Model numbers and lot codes: UDI-DI 18257200161010. Lots 001, 002, 003. Device: Pillar SA Ti, sterile, 37 mm W x 28 mm D x 18 mm H, 20-degrees. REF: 82-3713SP. Distribution: US nationwide in CO and CA. Quantity: 3.
No injuries or incidents have been reported.
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