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.
This recall is currently active, issued March 21, 2025. It was issued by Orthofix U.S. Llc.
- Company
- Orthofix U.S. Llc
- Recall Initiated
- February 20, 2025
- Posted
- March 21, 2025
- Recall Number
- Z-1432-2025
- Quantity
- 20
- Firm Location
- Lewisville, TX
- Official Source
- View on FDA website ↗
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.
Distribution
US Nationwide distribution in the states of California, Colorado, and Missouri.
Lot / Code Info
(1) REF 82-3300SP - Lot Number 001, UDI 18257200160426; (2) REF 82-3700SP - Lot Number 001, UDI 18257200160884; and (3) REF 82-4000SP - Lot Number 001, UDI 18257200161270.
Root Cause
Labeling Change Control
Action Taken
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