DJO EMPOWR 3D Knee — Class II medical device recall Z-1257-2022
Ongoing recall by Encore Medical, LP, reported 2022-06-15, distributed nationwide. A right, size 8, knee tibial insert package may include a mispackaged, left ,size 4, knee tibial insert. If im
| Recall number | Z-1257-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Encore Medical, LP, Austin, TX, United States |
| Recall initiated | 2022-05-05 |
| Classified | 2022-06-09 |
| Reported by FDA | 2022-06-15 |
| Distributed | Nationwide (US) |
| Quantity | 20 |
| Lot numbers | 078T1141 |
| Model numbers | 342-10-708 |
Product
DJO EMPOWR 3D Knee (Right) 10mm Tibial Insert, REF: 342-10-708
Reason for recall
A right, size 8, knee tibial insert package may include a mispackaged, left ,size 4, knee tibial insert. If implanted, a risk may include leaving debris in the joint space.
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-1257-2022. 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.