Device product
Logical cup liner - Product Usage: intended to replace a hip joint where bone stock is sufficient to support the implant.
Z-1694-2021
Product summary
- Event
- Event 87862
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3 units
- Official record key
device-enforcement:Z-1694-2021
Official wording
Reason: Product mislabeled, with the incorrect product inside the package.
Code information: LOT# 71541-1
Distribution pattern: US Nationwide distribution in the state of NC.
Derived failure modes
-
Labeling or packaging
mislabeled