Z-1524-2021 Class II Ongoing
FDA device recall Z-1524-2021 was initiated by Encore Medical, LP on Feb 5, 2021 and is designated Class II. Reason for recall: Incorrect assembly of a subcomponent by a vendor and as a result, the windows provided to show the size are facing the opposite direction. The recall status is ongoing. Affected quantity: 16 units.
Recall details
- Product Type
- Devices
- Report Date
- May 12, 2021
- Initiation Date
- Feb 5, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 16 units
Product description
DJO EMPOWR KNEE Femoral Sizer
Reason for recall
Incorrect assembly of a subcomponent by a vendor and as a result, the windows provided to show the size are facing the opposite direction.
Distribution pattern
U.S.: FL, IN, and MN O.U.S.: None
Code information
Model Number: 800-05-034 Lot Number: 326336L02
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1524-2021
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026