Class II — Encore Medical, LP
| Recalling firm | ENCORE MEDICAL, L.P. |
|---|---|
| Registered facility | View this company's 3 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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. |
| Product | DJO EMPOWR 3D Knee (Right) 10mm Tibial Insert, REF: 342-10-708 |
| Quantity | 20 |
| Distribution | U.S. Nationwide distribution in the states of TN, MN, IL, IN, SC, MS, CA, KS. |
| Initiated | 2022-05-05 |
| Classified | 2022-06-09 |
| Recall number | Z-1257-2022 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Encore Medical, LP (Z-1257-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/90230/
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