Class IIOngoingZ-1459-2026
Encore Medical, LP recalls Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS
Knee and Humeral socket implants contain incorrect labeling.
Encore Medical, LPTXMar 4, 2026
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1–12 of 20 recalls
Class IIOngoingZ-1233-2026
Encore Medical, LP recalls EMPOWR 3D Knee Tibial Insert 5R 14MM
942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discrepancy, which may cause surgical delay t…
- Polymer/Metal/Polymer Cemented Semi-Constrained Patellofemorotibial Knee Prosthesis
- Labeling Change Control
Encore Medical, LPTXFeb 11, 2026
Class IIOngoingZ-2541-2025
Waldemar Link GmbH & Co. KG (Mfg Site) recalls LinkSymphoKnee System
Some modular LinkSymphoKnee TiNbN Tibial Components were manufactured with two uncoated security screws, which is incorrect.
- Polymer/Metal/Polymer Cemented Semi-Constrained Patellofemorotibial Knee Prosthesis
- Under Investigation by firm
Waldemar Link GmbH & C…Sep 17, 2025
Class IIOngoingZ-2286-2025
Encore Medical, LP recalls Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS
Knee implants contain incorrect labeling (size and/or side incorrect)
- Polymer/Metal/Polymer Cemented Semi-Constrained Patellofemorotibial Knee Prosthesis
- Labeling Change Control
Encore Medical, LPTXAug 20, 2025
Class IIOngoingZ-2285-2025
Encore Medical, LP recalls Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS
Knee implants contain incorrect labeling (size and/or side incorrect)
- Polymer/Metal/Polymer Cemented Semi-Constrained Patellofemorotibial Knee Prosthesis
- Labeling Change Control
Encore Medical, LPTXAug 20, 2025
Class IIOngoingZ-2126-2025
Encore Medical, LP recalls Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS
Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. The use of this product may result in the incorrect product being selected. This could result in a revision surgery if used.
- Polymer/Metal/Polymer Cemented Semi-Constrained Patellofemorotibial Knee Prosthesis
- Packaging change control
Encore Medical, LPTXJul 23, 2025
Class IIOngoingZ-2125-2025
Encore Medical, LP recalls Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS
Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. The use of this product may result in the incorrect product being selected. This could result in a revision surgery if used.
- Polymer/Metal/Polymer Cemented Semi-Constrained Patellofemorotibial Knee Prosthesis
- Packaging change control
Encore Medical, LPTXJul 23, 2025
Class IIOngoingZ-2069-2025
CORIN MEDICAL, LTD. recalls Apex Knee System. Model Numbers: KC-50090
Investigation has identified that the age of the nylon packaging material has caused a loss of integrity of some pouches.
- Polymer/Metal/Polymer Cemented Semi-Constrained Patellofemorotibial Knee Prosthesis
- Nonconforming Material/Component
CORIN MEDICAL, LTD.Jul 9, 2025
Class IIOngoingZ-1702-2025
Waldemar Link GmbH & Co. KG (Mfg Site) recalls Tibial Augment
The device was delivered with a preassembled Femoral Augment screw that was missing its thread.
- Polymer/Metal/Polymer Cemented Semi-Constrained Patellofemorotibial Knee Prosthesis
- Nonconforming Material/Component
Waldemar Link GmbH & C…May 7, 2025
Class IIOngoingZ-1701-2025
Waldemar Link GmbH & Co. KG (Mfg Site) recalls L-Shaped Femoral Augment
The device was delivered with a preassembled Femoral Augment screw that was missing its thread.
- Polymer/Metal/Polymer Cemented Semi-Constrained Patellofemorotibial Knee Prosthesis
- Nonconforming Material/Component
Waldemar Link GmbH & C…May 7, 2025
Class IIOngoingZ-1700-2025
Waldemar Link GmbH & Co. KG (Mfg Site) recalls Posterior Femoral Augment
The device was delivered with a preassembled Femoral Augment screw that was missing its thread.
- Polymer/Metal/Polymer Cemented Semi-Constrained Patellofemorotibial Knee Prosthesis
- Nonconforming Material/Component
Waldemar Link GmbH & C…May 7, 2025
Class IIOngoingZ-1699-2025
Waldemar Link GmbH & Co. KG (Mfg Site) recalls Distal Femoral Augment
The device was delivered with a preassembled Femoral Augment screw that was missing its thread.
- Polymer/Metal/Polymer Cemented Semi-Constrained Patellofemorotibial Knee Prosthesis
- Nonconforming Material/Component
Waldemar Link GmbH & C…May 7, 2025