Orthofix recalls specific 37mm PILLAR SA Ti spinal fusion devices due to incorrect label width measurements. This labeling error may cause improper surgical use. Affected devices have UDI-DI: 18257200161010 and lots 001-003.
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.
Orthofix is recalling certain spinal fusion devices because their labels incorrectly state a 33mm width instead of the actual 37mm. This labeling error could lead to improper surgical use if the device is not correctly sized.
The device has a labeling discrepancy where the outer label and inner label both state a 33mm width instead of the correct 37mm. This could lead to improper surgical application if the device is not sized correctly for the patient's spine.
Patients who received the specific PILLAR SA Ti spinal fusion device with the incorrect labeling. Surgeons and medical staff who used these devices during procedures are also affected.
Check for the product name 'PILLAR SA Ti', sterile, 37mm width, 20-degree angle, and reference number 82-3713SP. Devices with UDI-DI: 18257200161010 and lots 001, 002, or 003 are affected.
Verify the device's width on the front label is 37mm and the inner label states 37mm, not 33mm.
The device has a labeling discrepancy where the outer label and inner label both state a 33mm width instead of the correct 37mm.
Check for the product name 'PILLAR SA Ti', sterile, 37mm width, 20-degree angle, reference number 82-3713SP, and UDI-DI: 18257200161010 with lots 001, 002, or 003.
The recall does not require immediate action; check the labels to ensure the correct width is stated.
We’ve drafted a message you can send Orthofix to request your refund or repair — edit it as you like.
Subject: Recall Z-2555-2025 — Orthofix Orthofix Hello, I own a Orthofix that is covered by recall Z-2555-2025 from Orthofix. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
