Z-0508-2024 Class II Ongoing
FDA device recall Z-0508-2024 was initiated by Encore Medical, LP on Nov 10, 2023 and is designated Class II. Reason for recall: Due to incorrect product/device within packaging. The recall status is ongoing. Affected quantity: 37 devices.
Recall details
- Product Type
- Devices
- Report Date
- Dec 13, 2023
- Initiation Date
- Nov 10, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 37 devices
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.
Distribution pattern
US Nationwide distribution.
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0508-2024
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026