Orthofix U.S. LLC: Medical Device Recall in 2025 - (Recall #: Z-2555-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: June 24, 2025

Date Posted: September 17, 2025

Recall Number: Z-2555-2025

Event ID: 97265

Reason for Recall:

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.

Status: Ongoing

Product Quantity: 3

Code Information:

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

Distribution Pattern:

US Nationwide distribution in the states of CO, CA.

Voluntary or Mandated:

Voluntary: Firm initiated