Device product
PILLAR SA Ti, STERILE, 37mm (W) x 28mm (D) x 18mm (H), 20-degrees, REF: 82-3713SP
Z-2555-2025
Product summary
- Event
- Event 97265
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3
- Official record key
device-enforcement:Z-2555-2025
Official wording
Reason: 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.
Code information: UDI-DI: 18257200161010, Lots: 001, 002, and 003
Distribution pattern: US Nationwide distribution in the states of CO, CA.
Derived failure modes
-
Labeling or packaging
labeling discrepancy with incorrect