Z-1524-2021 Class II Ongoing
FDA device recall Z-1524-2021 was initiated by Encore Medical, LP on February 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
- February 5, 2021
- Termination Date
- N/A
- 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