Device product
Lateral Troch Plate Full Crimp - 254mm, model # 350837
Z-0296-2018
Product summary
- Event
- Event 78167
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-0296-2018
Official wording
Reason: Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect.
Code information: Lot Number: 340530
Distribution pattern: Nationwide in US; Internationally Argentina, Netherlands & Canada
Derived failure modes
-
Labeling or packaging
label could be incorrect