Device product
DJO surgical EMPOWR Porous Knee System Empowr 3D Femur-Porous Coated SIZE 8 Left 3D MATRIX COATED REF 243-01-108 DJO surgical EMPOWR KNEE", PRESS FIT BP MINUS, 8L REF 353-03-108 For the treatment of patients who are candidates for knee arthroplasty per the Indication for use.
Z-0508-2024
Product summary
- Event
- Event 93465
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 37 devices
- Official record key
device-enforcement:Z-0508-2024
Official wording
Reason: Due to incorrect product/device within packaging.
Code information: Model Number: 243-01-108 UDI-DI Code: 00190446231295 Lot Number: 277W1114 Model Number: 353-03-108 UDI-DI Code: 00190446231295 Lot Number: 213W1051
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
Due to incorrect product/device within packaging.