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 | Tibial insert implant large boxes were labeled small and the small boxes were labeled large. If the incorrect labeling is identified this could lead to surgical delay and if the surgeon does not recognize the size discrepancy between the insert label and the pin label, the surgeon may implant the incorrect pin size. |
| Product | EMPOWR VVC KNEE TIBIAL INSERT, SIZE 6, 22MM, REF: 346-22-706; EMPOWR VVC KNEE TIBIAL INSERT, SIZE 7, 22MM, REF: 346-22-707; EMPOWR VVC KNEE TIBIAL INSERT, SIZE 8, 22MM, REF: 346-22-708; EMPOWR VVC KNEE TIBIAL INSERT, SIZE 9, 22MM, REF: 346-22-709; EMPOWR VVC KNEE TIBIAL INSERT, SIZE 10, 22MM, REF: 346-22-710; EMPOWR VVC KNEE TIBIAL INSERT, SIZE 11, 22MM, REF: 346-22-711; EMPOWR VVC KNEE TIBIAL INSERT, SIZE 5 BRIDGE UP, 22MM, REF: 346-22-755; EMPOWR VVC KNEE TIBIAL INSERT, SIZE 6 BRIDGE DOWN, 22MM, REF: 346-22-766; EMPOWR VVC KNEE TIBIAL INSERT, SIZE 2, 25MM, REF: 346-25-702; EMPOWR VVC KNEE TI… |
| Quantity | 216 |
| Distribution | US: MN, IL, IN, NY, FL |
| Initiated | 2022-12-22 |
| Classified | 2023-02-27 |
| Recall number | Z-1187-2023 |
| 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-1187-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/91494/
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