242 results
·
26ms
·
Sources: EU EUDAMED, US FDA
Filters
FDA Recall
×
Biomet OSS Letson Proximal Femoral Trial 7 cm resection/right, stainless steel, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-472088. A non-powered, orthopedic manual surgical instrument for use with other devices in orthopedic surgery.
FDA Recall
Terminated
·Biomet, Inc.·Product code KRO·May 19, 2009
Tibial Base Plates
FDA Recall
Terminated
·Smith & Nephew Inc·Product code KRO·June 21, 2004
Zimmer Most Hinged Tibia Baseplate Spacer, size 1, 6 mm, sterile, Zimmer, Warsaw, IN; REF 5020-06-001. Component used to augment uni- and bi-compartmental defects and is manufactured from Ti-6A1-4V Alloy.
FDA Recall
Terminated
·Zimmer Inc.·Product code KRO·January 29, 2009
USTAR II Hip System Press-Fit Curved Stem, RHS Ti Plasma Spray for the following reference numbers: REF: PE11151211 - 11x150mm, PE11151213 - 13x150mm, PE11151215 - 15x150mm, PE11151217 - 17x150mm, PE11151411 - 11x200mm, PE11151413 - 13x200mm, PE11151415 - 15x200mm, PE11151417 - 17x200mm,
FDA Recall
Open, Classified
·United Orthopedic Corporation No.·Product code KRO·January 3, 2024
DF Coated Integral Shaft & Stem 15x30x38; DF Coated Integral Shaft & Stem 15x36x44; DF Coated Integral Shaft & Stem 30x30x38; DF Coated Integral Shaft & Stem 30x36x44 The product is a component is a systems that is intended for the replacement if diseased or deficient bone around the knee joint, distal femur, proximal femur or total femur bone
FDA Recall
Terminated
·Stanmore Implants Worldwide Ltd.·Product code KRO·December 7, 2016
Segmental fluted stem, 18x250mm bwd, Sterile,
FDA Recall
Terminated
·Zimmer Biomet, Inc.·Product code KRO·February 28, 2017
smith&nephew, LEGION HK FEMORAL WEDGE (WEDGE AND SCREW), 5 MM, SIZE 5, REF 71422159, QTY: (1), STERILE The Revision Knee System Components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity levels are compatible with an adequate long-term result; failed osteotomies, unicompartmental replacement, or total knee replacement. The constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e., medial collateral and/or lateral collateral ligament) are absent or incompetent. The Revision Knee Components are for single use only and are intended for implantation with bone cement.
FDA Recall
Terminated
·Smith & Nephew, Inc.·Product code KRO·February 1, 2018
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/05;
FDA Recall
Open, Classified
·Waldemar Link GmbH & Co. KG (Mfg Site) Ost Str. 4-10 Norderstedt Germany·Product code KRO·January 12, 2026
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 8 CEM. Part Number: 150450108.
FDA Recall
Open, Classified
·DEPUY (IRELAND) Loughbeg, Ringaskiddy Co. Cork Ireland·Product code KRO·April 3, 2026
Biomet OSS Elliptical Proximal Femoral Trial 7 cm, right provisional, stainless steel, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-472124. A non-powered, orthopedic manual surgical instrument for use with other devices in orthopedic surgery.
FDA Recall
Terminated
·Biomet, Inc.·Product code KRO·May 19, 2009
MOST Options System Porous and Non-Porous Revision Stem Adapters, manufactured and distributed by Zimmer Austin, Inc., Austin, Texas 78717
FDA Recall
Terminated
·Zimmer Austin, Inc·Product code KRO·December 17, 2004
Biomet OSS Interlok IM Stem w/Screw, straight collar, 15 mm x 225 mm, TI6AL4V alloy, sterile, Biomet Orthopedics, Inc., Warsaw, IN; REF 150492. Orthopedic implant intended as part of a replacement knee joint.
FDA Recall
Terminated
·Biomet, Inc.·Product code KRO·May 15, 2008
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 45 MM Item Number: 15-2230/13
FDA Recall
Open, Classified
·Linkbio Corp.·Product code KRO·March 21, 2023
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 55 MM Item Number: 15-2230/10
FDA Recall
Open, Classified
·Linkbio Corp.·Product code KRO·March 21, 2023
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 55 MM Item Number: 15-2230/15
FDA Recall
Open, Classified
·Linkbio Corp.·Product code KRO·March 21, 2023
Medacta GMK HINGE, Tibial Insert Fixed, SIZE 2, HEIGHT 23 mm, REF 02.09.0223H, STERILE EO
FDA Recall
Terminated
·Medacta Usa Inc·Product code KRO·May 19, 2017
LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 5 LEFT, A/P 62 MM, M/L 70 MM, REF 71421375 The LEGION Hinge Knee System is indicated for: 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight and activity level are compatible with an adequate long-term result. 3. Failed osteotomies, unicompartmental replacement, or total knee replacement. 4. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, 5. Constrained and hinge knee systems are designed for use in patients in primary and revision surgery. The LEGION Hinge Knee System is for cemented use only.
FDA Recall
Terminated
·Smith & Nephew, Inc.·Product code KRO·May 26, 2016
Segmental fluted stem, 18x190mm str, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and Nail Implants
FDA Recall
Terminated
·Zimmer Biomet, Inc.·Product code KRO·February 28, 2017
RED SEXP DSTL FEM 19CM LT ASSY, model # CP111828
FDA Recall
Terminated
·Zimmer Biomet, Inc.·Product code KRO·June 5, 2017
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 3 CEM. Part Number: 150450203.
FDA Recall
Open, Classified
·DEPUY (IRELAND) Loughbeg, Ringaskiddy Co. Cork Ireland·Product code KRO·April 3, 2026