Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer
Orthopedic · 21 CFR 888.3510
Recent MDR events
9,364 adverse event reports on file
- ELEOS¿ Limb Salvage SystemJul 31, 2026InjuryOnkos Surgical Inc.3013450937-2026-00270
- ELEOS¿ Limb Salvage SystemJul 31, 2026InjuryOnkos Surgical Inc.3013450937-2026-00272
- ELEOS¿ Limb Salvage SystemJul 31, 2026InjuryOnkos Surgical Inc.3013450937-2026-00276
- ELEOS¿ Limb Salvage SystemJul 31, 2026InjuryOnkos Surgical Inc.3013450937-2026-00271
- ATTUNE LPSJul 28, 2026InjuryDepuy Ireland - 96166711818910-2026-12813
- ELEOS¿ Limb Salvage SystemJul 28, 2026InjuryOnkos Surgical Inc.3013450937-2026-00264
- ELEOS¿ Limb Salvage SystemJul 28, 2026InjuryOnkos Surgical Inc.3013450937-2026-00267
- ELEOS¿ Limb Salvage SystemJul 28, 2026InjuryOnkos Surgical Inc.3013450937-2026-00266
- ELEOS¿ Limb Salvage SystemJul 28, 2026InjuryOnkos Surgical Inc.3013450937-2026-00265
- ELEOS¿ Limb Salvage SystemJul 28, 2026InjuryOnkos Surgical Inc.3013450937-2026-00268
Event type breakdown
Recalls
123 recall events for this product code
- Waldemar Link GmbH & Co. KG (Mfg Site)Open, ClassifiedAug 11, 2026
Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge
The affected Endo-Model replacement set for a Rotating Hinge tibial plateau incorrectly contains a Pure Hinge plateau. The incorrect plateau could lead to a prolonged or modified surgery as the plateau cannot be inserted and an alternative product would be needed. If the incorrect plateau were to be implanted, this is associated with increased risk of wear, which could result in a reduced standing time of the implant.
Z-2934-2026 · View FDA record ↗ - United Orthopedic Corp.Open, ClassifiedAug 5, 2026
Brand Name: USTAR II Knee System
Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
Z-2884-2026 · View FDA record ↗ - DEPUY (IRELAND)Open, ClassifiedJun 29, 2026
Depuy Synthes, ATTUNE Revision Hinge Knee Hinge Housing Components with the below product descriptions and Part Codes.
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
Z-2616-2026 · View FDA record ↗ - DEPUY (IRELAND)Open, ClassifiedJun 29, 2026
Depuy Synthes, ATTUNE Revision Hinge Knee Hinge Insert Components with the below product descriptions and Part Codes.
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
Z-2617-2026 · View FDA record ↗ - DEPUY (IRELAND)Open, ClassifiedApr 29, 2026
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 4 CEM. Part Number: 150450104.
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
Z-1985-2026 · View FDA record ↗ - DEPUY (IRELAND)Open, ClassifiedApr 29, 2026
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 5 CEM. Part Number: 150450105.
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
Z-1986-2026 · View FDA record ↗ - DEPUY (IRELAND)Open, ClassifiedApr 29, 2026
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 7 CEM. Part Number: 150450107.
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
Z-1987-2026 · View FDA record ↗ - DEPUY (IRELAND)Open, ClassifiedApr 29, 2026
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 8 CEM. Part Number: 150450108.
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
Z-1988-2026 · View FDA record ↗ - DEPUY (IRELAND)Open, ClassifiedApr 29, 2026
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 3 CEM. Part Number: 150450203.
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
Z-1989-2026 · View FDA record ↗ - DEPUY (IRELAND)Open, ClassifiedApr 29, 2026
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 4 CEM. Part Number: 150450204.
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
Z-1990-2026 · View FDA record ↗
Registered firms
575 firms currently registered for this product code
Caragh Precision
Galway, IE
Biomet Chile S.a.
Santiago de Chile Region Metropolitana, CL
Zimmer Biomet Taiwan Co., Ltd.
Taipei, TW
Onkos Surgical, Inc.
Parsippany, NJ, US
Suzhou Elite Precision Machinery Co., Ltd.
Kunshan Jiangsu, CN
Biomet, Inc.
WARSAW, IN, US
Orchid Orthopedics-chelsea
Chelsea, MI, US
Bgs Beta-gamma-service Gmbh & Co Kg
Wiehl North Rhine-Westphalia, DE
Zimmer Biomet Korea Ltd.
Seoul, KR
Zimmer, Inc.
WARSAW, IN, US
Sterigenics Us Llc
West Memphis, AR, US
Symmetry Medical Manufacturing Inc
CLAYPOOL, IN, US
Zimmer (shanghai) Medical International Trading Co., Ltd.
Shanghai, CN
Zimmer Orthopedic Mfg Ltd
Shannon Clare, IE
Symmetry Medical Manufacturing Inc.
WARSAW, IN, US
Isomedix Operations Inc.
S Plainfield, NJ, US
Paragon Medical Device (changzhou) Co., Ltd.
Changzhou Jiangsu, CN
Zimmer Pte. Ltd.
Singapore South East, SG
Viant As&o Holdings, Llc
Brimfield, MA, US
510(k) clearances
87 clearances for this product code
- Howmedica Osteonics Corp. dba Stryker OrthopaedicsAug 6, 2026
K261898 · Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System
- Howmedica Osteonics Corp., Dba Stryker OrthopaedicsDec 15, 2025
K252898 · Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella; Triathlon® Symmetric Patella; Triathlon® Asymmetric Patella; Scorpio® Universal Dome Patella; Triathlon® Hinge Bumper
- United Orthopedic CorporationAug 22, 2025
K252303 · Stem Extension Line (USTAR II System)
- Howmedica Osteonics Corp., Dba Stryker OrthopaedicsJul 25, 2025
K251665 · Triathlon® Hinge Knee System
- Depuy Ireland UCNov 21, 2024
K242871 · ATTUNE Revision Hinge Knee
- Microport Orthopedics, Inc.Apr 1, 2024
K240043 · EVOLUTION® Hinge Knee System;GUARDIAN limb Salvage System;DCW Modular Distal Femoral System;REPIPHYSIS Limb Salvage System;EVOLUTION® MP Total Knee System; EVOLUTION® MP Total Knee System; EVOLUTION® MP Adaptive CS Insert; EVOLUTION® MP Adaptive PS Tibial Insert; EVOLUTION® MP CS/CR Porous Femur/EVOLUTION® Adaptive CS and PS Inserts; EVOLUTION® Revision CCK System; ADVANCE® Double High Insert; ADVANCE® A-CLASS® Tibial Insert; ADVANCE® Knee System; ADVANCE® Ultra-Congruent Tibial Inse
- Depuy Ireland UCMar 21, 2024
K233980 · ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System
- Microport Orthopedics, Inc.Sep 27, 2023
K230563 · EVOLUTION® Hinge Knee System