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.
Reported: December 13, 2023 Initiated: November 10, 2023 #Z-0508-2024
Product Description
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.
Reason for Recall
Due to incorrect product/device within packaging.
Details
- Recalling Firm
- Encore Medical, LP
- Units Affected
- 37 devices
- Distribution
- US Nationwide distribution.
- Location
- Austin, TX
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Encore Medical, LP. Units affected: 37 devices.
Why was this product recalled? ▼
Due to incorrect product/device within packaging.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 13, 2023. Severity: Moderate. Recall number: Z-0508-2024.
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