Device product
CARROLLTON HIP FX Convenience kit used for surgical procedures, SKU SYNJ910003A
Z-0349-2025
Product summary
- Event
- Event 95563
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 36 units
- Official record key
device-enforcement:Z-0349-2025
Official wording
Reason: Products within a Medline pack may be impacted by a packaging error in which an incomplete seal has formed on the packaging thereby creating a packaging seal gap.
Code information: UDI-DI:10889942848447; Lot Number: 24EBP466
Distribution pattern: US Nationwide distribution in the state of TN.
Derived failure modes
-
Labeling or packaging
packaging error