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Recall Observatory FDA recall evidence

Device product

PILLAR SA Ti, STERILE, 37mm (W) x 28mm (D) x 18mm (H), 20-degrees, REF: 82-3713SP

Z-2555-2025

June 24, 2025

Class II

Product summary

Firm
Orthofix U.S. LLC
Event
Event 97265
Status
Ongoing
Classification
Class II
Quantity
3
Official record key
device-enforcement:Z-2555-2025

Official wording

Reason: 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.

Code information: UDI-DI: 18257200161010, Lots: 001, 002, and 003

Distribution pattern: US Nationwide distribution in the states of CO, CA.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    labeling discrepancy with incorrect