Orthofix U.S. LLC: Device Recall
Recall #Z-2555-2025 · 06/24/2025
Class II: Risk
Recall Details
- Recall Number
- Z-2555-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Orthofix U.S. LLC
- Status
- Ongoing
- Date Initiated
- 06/24/2025
- Location
- Lewisville, TX, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3
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.
Product Description
PILLAR SA Ti, STERILE, 37mm (W) x 28mm (D) x 18mm (H), 20-degrees, REF: 82-3713SP
Distribution Pattern
US Nationwide distribution in the states of CO, CA.
Other Recalls by Orthofix U.S. LLC
- Class III: Low Risk 11/03/2025
- Class III: Low Risk 11/03/2025
- Class III: Low Risk 11/03/2025
- Class III: Low Risk 11/03/2025
- Class III: Low Risk 11/03/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.