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.
Recall
- Recall Number
- Z-1432-2025
- Event Number
- 96351
- Firm
- Orthofix U.S. LLC
- FEI Number
- 2183449
- Product Code
- MAX
- Status
- Open, Classified
- Root Cause
- Labeling Change Control
- Initiated
- February 20, 2025
- Posted
- March 21, 2025
- Address
- 3451 Plano Pkwy, Lewisville, TX, 75056-9453
Description
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.
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.
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]
US Nationwide distribution in the states of California, Colorado, and Missouri.
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