Z-2555-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- September 17, 2025
- Initiation Date
- June 24, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3
Product Description
PILLAR SA Ti, STERILE, 37mm (W) x 28mm (D) x 18mm (H), 20-degrees, REF: 82-3713SP
Reason for Recall
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.
Distribution Pattern
US Nationwide distribution in the states of CO, CA.
Code Information
UDI-DI: 18257200161010, Lots: 001, 002, and 003