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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:204437

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.

Official recall number

Z-0508-2024

Evidence summary

Product code
MBH
Recall status
Open, Classified
Event initiated
November 10, 2023
Root cause
Labeling Change Control
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-0508-2024

Field note

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