PILLAR SA Ti, STERILE, 37mm (W) x 28mm (D) x 18mm (H)… recallZ-2555-2025 · Orthofix U.S. LLC · initiated Jun 24, 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
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.
FDA root cause category: Labeling design
What the company is doing
On 6/24/2025, recall notes were emailed to customers who were asked to do the following: 1) Examine your inventory and quarantine any affected product. 2) If implanted, healthcare Providers should determine whether it is necessary to inform the patient, based on clinical judgment and individual circumstances. 3) This notice should be shared with all relevant personnel within your organization and forwarded to any other organization or facility where potentially affected devices may have been transferred. 4) Complete and return the response form to the firm. Should you have any questions regarding this matter, please contact the firm at [email protected]
Recall details
- Recall number
- Z-2555-2025
- Status
- Open, Classified
- Initiated by the company
- Jun 24, 2025
- Posted by the FDA
- Sep 11, 2025
- Recalling firm
- Orthofix U.S. LLC
- Quantity
- 3
- Product code
- MAX
- FDA submissions
- K240749
- Distribution
- US Nationwide distribution in the states of CO, CA.
Product description
PILLAR SA Ti, STERILE, 37mm (W) x 28mm (D) x 18mm (H), 20-degrees, REF: 82-3713SP
Code information (models, lots, serial numbers)
UDI-DI: 18257200161010, Lots: 001, 002, and 003
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- 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
Other devices under the same FDA submission
3 devices 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.
- 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
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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