Recall Z-1432-2025 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Orthofix U.S. LLC
Orthofix Pillar SA Ti Spacer System Intervertebral Body Fusion Spinal Device, sterile, implant grade titanium alloy: (1) REF 82-3300SP, 33mm W x 24mm D x 10mm H, 7 degrees; (2) REF 82-3700SP, 37mm W x 28mm D x 10mm H, 7 degrees; and (3) REF 82-4000SP, 40mm W x 32mm D x 10mm H, 7 degrees.
| Date | Mar 21, 2025 (initiated Feb 20, 2025) |
| Status | Open, Classified |
| Reason | The product is mislabeled with the incorrect anterior height of 10mm, but the laser marking on the implant and corresponding trial both show the correct anterior height of 10.5mm. |
| Root cause | Labeling Change Control |
| Action | On 2/20/2025, correction notices were emailed to distributors who were informed of the following: This notice should be shared with anyone who needs to be aware within your organization and forwarded to any organization where potentially affected devices have been transferred. Attach this notice to the inventory in your possession, if possible. Should you have any questions regarding this matter, please contact the firm at madison.ebel@seaspine.com |
| Quantity | 20 |
| Distribution | US Nationwide distribution in the states of California, Colorado, and Missouri. |
| 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 |