PILLAR SA Ti, STERILE, 37mm (W) x 28mm (D) x 18mm (H), 20-degrees, REF: 82-3713SP
Reported: September 17, 2025 Initiated: June 24, 2025 #Z-2555-2025
Product Description
PILLAR SA Ti, STERILE, 37mm (W) x 28mm (D) x 18mm (H), 20-degrees, REF: 82-3713SP
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.
Details
- Recalling Firm
- Orthofix U.S. LLC
- Units Affected
- 3
- Distribution
- US Nationwide distribution in the states of CO, CA.
- Location
- Lewisville, TX
Frequently Asked Questions
What product was recalled? ▼
PILLAR SA Ti, STERILE, 37mm (W) x 28mm (D) x 18mm (H), 20-degrees, REF: 82-3713SP. Recalled by Orthofix U.S. LLC. Units affected: 3.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 17, 2025. Severity: Moderate. Recall number: Z-2555-2025.
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