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Orthofix U.S. LLC recalls PILLAR SA Ti, STERILE, 37mm (W) x 28mm (D) x 18mm (H), 20-degrees, REF: 82-3713SP
Recalled September 17, 2025 · FDA recall Z-2555-2025 · Orthofix U.S
Hazard
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 Class II
Units
3
Sold at
US Nationwide distribution in the states of CO, CA.
Description
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.
Product
PILLAR SA Ti, STERILE, 37mm (W) x 28mm (D) x 18mm (H), 20-degrees, REF: 82-3713SP
Manufacturer(s)
Orthofix U.S. LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →