Device product
Vanguard Knee System -PS Open Box Femoral Left, 62.5 mm Item Number: 183126
Z-0495-2019
Product summary
- Event
- Event 81472
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8 units
- Official record key
device-enforcement:Z-0495-2019
Official wording
Reason: Label on the outer carton or the patient labels does not match label on the inner sterile packaging
Code information: Lot Number: J6255863 UDI: (01)00880304270794(17)280411(10)J6265594
Distribution pattern: AR, MO, MN, NJ, NY, OH, MN , NJ, VA
Derived failure modes
-
Unknown
Label on the outer carton or the patient labels does not match label on the inner sterile packaging