EMPOWR VVC KNEE TIBIAL INSERT — Class II medical device recall Z-1187-2023
Ongoing recall by Encore Medical, LP, reported 2023-03-08, distributed in FL, IL, IN, MN, NY. Tibial insert implant large boxes were labeled small and the small boxes were labeled large. If the incorrect
| Recall number | Z-1187-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Encore Medical, LP, Austin, TX, United States |
| Recall initiated | 2022-12-22 |
| Classified | 2023-02-27 |
| Reported by FDA | 2023-03-08 |
| Distributed | FL, IL, IN, MN, NY |
| Quantity | 216 |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00190446219378, 00190446219385, 00190446219392, 00190446219408, 00190446219415, 00190446219422, 00190446219439, 00190446219477, 00190446219507, 00190446219569, 00190446219583, 00190446219590, 00190446219781, 00190446219798 |
| Lot numbers | 00190446219378/484V1013, 00190446219385/485V1001, 00190446219392/486V1005, 00190446219408/487V1001, 00190446219415/488V1003, 00190446219422/489V1003, 00190446219439/490V1001, 00190446219477/491V1002, 00190446219507/492V1002, 00190446219569/493V1001, 00190446219583/494V1001, 00190446219590/495V1001, 00190446219798/503V1003, 346-22-706, 346-22-707, 346-22-708, 346-22-709, 346-22-710, 346-22-711, 346-22-755, 346-22-766, 346-25-702, 346-25-703, 346-25-704, 346-25-705, 346-25-755, 346-25-766, 484V1014, 484V1015, 484V1016, 484V1017, 484V1018, 485V1002, 485V1003, 485V1004, 486V1006, 486V1007, 486V1008, 487V1002, 487V1003 and 31 more |
| Model numbers | 346-22-706, 346-22-707, 346-22-708, 346-22-709, 346-22-710, 346-22-711, 346-22-755, 346-22-766, 346-25-702, 346-25-703, 346-25-704, 346-25-705, 346-25-755, 346-25-766 |
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 TIBIAL INSERT, SIZE 3, 25MM, REF: 346-25-703; EMPOWR VVC KNEE TIBIAL INSERT, SIZE 4, 25MM, REF: 346-25-704; EMPOWR VVC KNEE TIBIAL INSERT, SIZE 5, 25MM, REF: 346-25-705; EMPOWR VVC KNEE TIBIAL INSERT, SIZE 5 BRIDGE UP, 25MM, REF: 346-25-755; EMPOWR VVC KNEE TIBIAL INSERT, SIZE 6 BRIDGE DOWN, 25MM, REF: 346-25-766
Reason for recall
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.
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-1187-2023. 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.