DJO surgical EMPOWR Porous Knee System Empowr 3D Femur-Porous Coated… — Class II medical device recall Z-0508-2024
Ongoing recall by Encore Medical, LP, reported 2023-12-13, distributed nationwide. Due to incorrect product/device within packaging.
| Recall number | Z-0508-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Encore Medical, LP, Austin, TX, United States |
| Recall initiated | 2023-11-10 |
| Classified | 2023-12-07 |
| Reported by FDA | 2023-12-13 |
| Distributed | Nationwide (US) |
| Quantity | 37 devices |
| UPC / GTIN / UDI-DI | 00190446231295 |
| Lot numbers | 213W1051, 277W1114 |
| Model numbers | 243-01-108, 243-01-108DJO, 353-03-108 |
Product
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.
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-0508-2024. 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.