PILLAR SA Ti recallZ-1432-2025 · Orthofix U.S. LLC · initiated Feb 20, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Orthofix U.S. LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The product is mislabeled with the incorrect anterior height of 10mm, but the laser marking on the implant and corresponding trial both show the correct anterior height of 10.5mm.
FDA root cause category: Labeling Change Control
What the company is doing
On 2/20/2025, correction notices were emailed to distributors who were informed of the following: This notice should be shared with anyone who needs to be aware within your organization and forwarded to any organization where potentially affected devices have been transferred. Attach this notice to the inventory in your possession, if possible. Should you have any questions regarding this matter, please contact the firm at [email protected]
Recall details
- Recall number
- Z-1432-2025
- Status
- Open, Classified
- Initiated by the company
- Feb 20, 2025
- Posted by the FDA
- Mar 21, 2025
- Recalling firm
- Orthofix U.S. LLC
- Quantity
- 20
- Product code
- MAX
- FDA submissions
- K240749
- Distribution
- US Nationwide distribution in the states of California, Colorado, and Missouri.
Product description
Orthofix Pillar SA Ti Spacer System Intervertebral Body Fusion Spinal Device, sterile, implant grade titanium alloy: (1) REF 82-3300SP, 33mm W x 24mm D x 10mm H, 7 degrees; (2) REF 82-3700SP, 37mm W x 28mm D x 10mm H, 7 degrees; and (3) REF 82-4000SP, 40mm W x 32mm D x 10mm H, 7 degrees.
Code information (models, lots, serial numbers)
(1) REF 82-3300SP - Lot Number 001, UDI 18257200160426; (2) REF 82-3700SP - Lot Number 001, UDI 18257200160884; and (3) REF 82-4000SP - Lot Number 001, UDI 18257200161270.
Devices named in this recall
3 devices in the FDA device registry whose identifier appears in the recall's code information.
- PILLAR SA Ti 82-3300SPOrthofix US LLC · Intervertebral fusion device with bone graft, lumbar1 recall0 reports
- PILLAR SA Ti 82-3700SPOrthofix US LLC · Intervertebral fusion device with bone graft, lumbar1 recall0 reports
- PILLAR SA Ti 82-4000SPOrthofix US LLC · Intervertebral fusion device with bone graft, lumbar1 recall0 reports
Product lines
Other devices under the same FDA submission
1 device cleared under K240749 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- 37mm W X 28mm D X 18mm H, 20°, PILLAR SA Ti, STERILE 82-3713SPOrthofix US LLC · Intervertebral Fusion Device With Integrated Fixation, Lumbar1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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