Device product
WRIGHT EVOLVE Proline Head, Size: +2, OD: 20mm, REF 496H220
Z-1101-2020
Product summary
- Event
- Event 84673
- Status
- Terminated
- Classification
- Class II
- Quantity
- 39 devices
- Official record key
device-enforcement:Z-1101-2020
Official wording
Reason: Two lots of EVOLVE Modular Radial Head could have the wrong size product in the package. Both the label and laser marking are incorrect on the affected product.
Code information: Lot Code 1633010
Distribution pattern: US
Derived failure modes
-
Labeling or packaging
label and laser marking are incorrect