FDA Device recall Z-1524-2021
DJO EMPOWR KNEE Femoral Sizer
- FDA Device
- Class II
- ongoing
- Published 2021-05-12
On 2021-05-12 the FDA classified a Class II recall of DJO EMPOWR KNEE Femoral Sizer by Encore Medical, citing incorrect assembly of a subcomponent by a vendor and as a result, the windows provided to show the size are facing the opposite direction.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1524-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-02-05 |
| Published | 2021-05-12 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Encore Medical |
| Distribution | FL, IN, MN |
Product
DJO EMPOWR KNEE Femoral Sizer
Reason
Incorrect assembly of a subcomponent by a vendor and as a result, the windows provided to show the size are facing the opposite direction.
Identifiers
| code_info | Model Number: 800-05-034 Lot Number: 326336L02 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1524-2021%22
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