Recall Z-2555-2025— Orthofix U.S. LLC
Class II · Ongoing
Class II FDA medical device recall by Orthofix U.S. LLC, initiated 2025-06-24. It names one FDA 510(k) clearance: K240749. Product: PILLAR SA Ti, STERILE, 37mm (W) x 28mm (D) x 18mm (H), 20-degrees, REF: 82-3713SP. 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..
- Recalling firm
- Orthofix U.S. LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-06-24
- Firm location
- Lewisville, TX, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.