Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Number: 341-14-711 Product Description: Enovis knee devices are for knee arthroplasty.
USBrand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Number: 341-14-711 Product Description: Enovis knee devices are for knee arthroplasty.
Recalling Firm: Encore Medical, LP
Reason for Recall / Hazard
Due to packaging discrepancy with incorrect product size mixed up.
Product Description & Identification
Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Number: 341-14-711 Product Description: Enovis knee devices are for knee arthroplasty.
Additional Source Details
| Field | Value |
|---|---|
| City | Austin |
| State | TX |
| Event id | 98700 |
| Address 1 | 9800 Metric Blvd |
| Address 2 | N/A |
| Code info | Model/Catalog Number: 341-14-711 Lot Code: Lot: 145T1067 and 135T1060 GTIN: 00888912167086 Expiration Date: 12-06-2026 (145T1067) 12-07-2026 (135T1060) |
| Postal code | 78758-5445 |
| Report date | 20260715 |
| Product type | Devices |
| Product quantity | 8 |
| Reason for recall | Due to packaging discrepancy with incorrect product size mixed up. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260216 |
| Initial firm notification | Letter |
| Center classification date | 20260708 |
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Overview
- Recalling FirmEncore Medical, LP
- StatusOngoing
- Risk LevelClass II
- DistributionGL112 Certus Medical LLC Indiana (IN) & Michigan (MI) 342-19-703 177T1057 EMPOWR 3D KNEETM INS, 3R 19MM, VE 1 MW001 Fox Medtech, LLC Colorado (CO), Wyoming (WY), Montana (MT), Counties in Nebraska 342-19-703 177T1057 EMPOWR 3D KNEETM INS, 3R 19MM, VE 1 NE190 Implant Medical Sales, Inc. New York (NY) 342-19-703 177T1057 EMPOWR 3D KNEETM INS, 3R 19MM, VE 1 SE180 Joint Medical Solutions, L.L.C. Alabama (AL) 342-19-703 177T1057 EMPOWR 3D KNEETM INS, 3R 19MM, VE 1 GL108 Great Lakes Medical Illiniois (IL) 341-14-711 135T1060 EMPOWR 3D KNEETM INS, 11L 14MM, VE 2 GL112 Certus Medical LLC Indiana (IN) & Michigan (MI) 341-14-711 135T1060 EMPOWR 3D KNEETM INS, 11L 14MM, VE 1 CE120 Matrix Orthopedics Surgical Devices Dallas/Fort Worth, TX 342-14-711 145T1067 EMPOWR 3D KNEETM INS, 11R 14MM, VE 1 NW105 Kinetic Medicine South Dakota (SD), Eastern Nebraska (NE), Western Iowa (IA) 342-14-711 145T1067 EMPOWR 3D KNEETM INS, 11R 14MM, VE 2 MA102 ProCore Medical LLC - NC North Carolina (NC) 342-14-711 145T1067 EMPOWR 3D KNEETM INS, 11R 14MM, VE 1 Total 11
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🚨 SAFETY ALERT: Encore Medical, LP - Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Number: 341-14-711 Product Description: Enovis knee devices are for knee arthroplasty. Check if your household is affected: https://therecallfile.com/recalls/brand-name-empowr-3d-knee-product-name-empowr-3d-knee-ins-11l-14mm-ve/FDA-Z-2701-2026
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