Device product
LINK SymphoKnee Patella Sizing Template, Item Number 881-509/00
Z-2445-2024
Product summary
- Firm
- LINK BIO CORP
- Event
- Event 94926
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 8 units
- Official record key
device-enforcement:Z-2445-2024
Official wording
Reason: The LinkSymphoKnee Patella Sizing Template was incorrectly labeled. The markings on two arms of the instrument were mixed up because the triangular Patella Sizing Template was inserted upside down into the laser marking process.
Code information: Item Number: 881-509/00; UDI-DI: 04026575310203; Lot number: C225066.
Distribution pattern: US Nationwide distribution in the states of FL, GA, KS, OH, WI.
Derived failure modes
-
Labeling or packaging
incorrectly labeled