DJO EMPOWR KNEE Femoral Sizer — Class II medical device recall Z-1524-2021
Ongoing recall by Encore Medical, LP, reported 2021-05-12, distributed in FL, IN, MN. Incorrect assembly of a subcomponent by a vendor and as a result, the windows provided to show the size are fa
| Recall number | Z-1524-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Encore Medical, LP, Austin, TX, United States |
| Recall initiated | 2021-02-05 |
| Classified | 2021-04-30 |
| Reported by FDA | 2021-05-12 |
| Distributed | FL, IN, MN |
| Quantity | 16 units |
| Lot numbers | 326336L02 |
| Model numbers | 800-05-034 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1524-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.