Recall Z-2555-2025 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Orthofix U.S. LLC
PILLAR SA Ti, STERILE, 37mm (W) x 28mm (D) x 18mm (H), 20-degrees, REF: 82-3713SP
| Date | Sep 11, 2025 (initiated Jun 24, 2025) |
| Status | Open, Classified |
| 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. |
| Root cause | Labeling design |
| Action | On 6/24/2025, recall notes were emailed to customers who were asked to do the following: 1) Examine your inventory and quarantine any affected product. 2) If implanted, healthcare Providers should determine whether it is necessary to inform the patient, based on clinical judgment and individual circumstances. 3) This notice should be shared with all relevant personnel within your organization and forwarded to any other organization or facility where potentially affected devices may have been transferred. 4) Complete and return the response form to the firm. Should you have any questions |
| Quantity | 3 |
| Distribution | US Nationwide distribution in the states of CO, CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K240749 | PILLAR SA Ti Spacer System (82-XXX) Orthofix, Inc., May 28, 2024 |