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.
FDA Recall Z-1432-2025 · Posted 2025-03-21
Recalling FirmOrthofix U.S. LLC
Recall StatusOpen, Classified
Product CodeMAX
Date Initiated2025-02-20
Product Quantity20
Reason for Recall
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.
Firm 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 [email protected]
Root Cause
Labeling Change Control
Distribution Pattern
US Nationwide distribution in the states of California, Colorado, and Missouri.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.