335 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Zimmer Alumina ceramic femoral head; 26 mm diameter alumina head with a +3.0 neck length on Co-Cr 12/14 tapers. Cat. No. 6418-26-03.
FDA Recall
Terminated
·Zimmer Inc.·Product code LZO·January 6, 2003
OnmiFit HFx Surgical Protocol 127 degree and 132 degree Surgical Protocol; Stryker, 325 Corporate Drive, Mahwah, NJ 07430. Surgical protocols instruct surgeons on proper surgical technique.
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code LZO·August 31, 2009
Stryker Restoration ADM System Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 Stryker France ZAC Satolos Green Pusignan Av de Satolas Green 69881 Mey Sieu Cedex France The Restoration ADM is a sterile, single-use device intended for use in primary and revision total hip arthroplasty to alleviate pain and restore function. This device is intended to be used only with any currently available Howmedica Osteonics 22.2 mm and 28 mm diameter femoral heads.
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code LZO·June 3, 2011
Alloclassic SL Shaft
FDA Recall
Terminated
·Zimmer, Inc.·Product code LZO·September 4, 2012
Secur-Fit Max Hip Stem These devices are modular components of a total hip system. These femoral stems are intended for use with femoral heads and acetabular components in primary or revision total hip arthroplasty.
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code LZO·November 13, 2008
Ovation Hip Stem, REF 201-0102, Offset Stem Inserter RT, Non-Sterile, Ortho Development, Draper, Utah 84020. The Ovation Hip System is intended for use in total hip arthroplasty. The hip stem inserter is an instrument used to seat the hip stem in the femur. There is a notch in the top of the hip stem, and the hip stem inserter has a corresponding tip at the end of the instrument. The tip of the inserter is designed to fit into the notch of the hip stem, as a guide. Once this is inserted, the surgeon will tap on the opposite end of the inserter with a hammer to seat the press-fitted stem assembly.
FDA Recall
Terminated
·Ortho Development Corporation·Product code LZO·January 11, 2011
Trinity Acetabular Shell Product Usage Total Hip Replacement.
FDA Recall
Terminated
·Corin USA Limited·Product code LZO·January 29, 2016
Avenir Mller Stem 4 Standard Avenir Mller Stem 6 Lateral Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Intended Use: " Advanced wear of the joint due to degenerative, post-traumatic or rheumatic diseases. " Failed previous hip surgery including joint reconstruction (osteotomy), arthrodesis, hemiarthroplasty or total hip replacement (THR). " Acute traumatic fracture of the femoral head or neck " Avascular necrosis of the femoral head. " Avenir Moller Stems are for cementless use only.
FDA Recall
Terminated
·Product code LZO·June 30, 2016
LINK STEM with Microporous Surface MP Reconstruction Prosthesis, CEMENTLESS (Size XS-0, D: 12mm, L: 160mm), Reference Number 172-916/12 Product Usage: The LINK STEM with Microporous Surface MP Reconstruction Prosthesis, CEMENTLESS System is indicated for patients with mobility-limiting diseases, fractures or defects which cannot be treated by conservative or osteosynthetic procedures. The LINK STEM with Microporous Surface MP Reconstruction Prosthesis, CEMENTLESS System is indicated for the following conditions: Revision arthroplasty due to juxta-articular bone defects Revision of loosened femoral prosthesis components involving extensive bone resorption of the proximal femur and widening of the medullary cavity or marked thinning of proximal femoral cortical bone Revision of loosened femoral prosthesis components with periprosthetic/subprosthetic fracture Deformed proximal femur due to fractures or osteotomies Correction of bone deficiencies, e.g. due to tumors Large post-revision and post-trauma segmental bone defects Oncological and revision surgery from tibial to hip area (in conjunction with Endo-Model SL Rotational and Hinge Knee Prostheses) The device is intended for cemented and cementless use.
FDA Recall
Terminated
·Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany·Product code LZO·December 7, 2018
Medacta International MiniMAX CEMENTLESS ANATOMICAL STEM, 12/14: for cementless use in total or partial hip arthroplasty in primary or revision surgery.
FDA Recall
Terminated
·Medacta Usa Inc·Product code LZO·November 15, 2017
OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Serf Dual Mobility Cup Insert Liner 51-28; Product code: H6-25128
FDA Recall
Terminated
·OMNIlife science Inc.·Product code LZO·July 23, 2019
Zimmer Alumina ceramic femoral head; 26 mm diameter alumina head with a 0 neck length on Co-Cr 12/14 tapers . Cat. No. 6418-26-02.
FDA Recall
Terminated
·Zimmer Inc.·Product code LZO·January 6, 2003
Biomet Modular TTPA Ceramic Head, 28 mm head diameter plus 5 mm neck, sterile, Biomet Orthopedics, Inc., Warsaw, IN; Catalog Number: RD115112. A hip joint metal/ceramic/polymer semiconstrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint.
FDA Recall
Terminated
·Biomet, Inc.·Product code LZO·March 16, 2009
Restoration Modular Cone Bodies; titanium Alloy and Hydroxyapatite, Sterile. Catalog number 6276-1-021, Catalog number 6276-1-025, Catalog number 6276-1-219, and Catalog number 6276-1-325. Howmedica Osteonics Corp, Stryker Ireland, Carrighwohill Sterile. Intended Use: For primary or revision total hip arthroplasty and severe proximal bone loss. Stems are intended to be used with Howmedica Osteonics femoral heads, unipolar and bipolar components, and acetabular components. Conditions for which product may be appropriate for use: rheumatoid arthritis, correction of deformity, non-inflammatory degenerative joint disease, revision surgery, treatment of non-union, fracture of proximal femur with head involvement.
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code LZO·April 2, 2009
RETi-LOCK Cluster-Hole Acetabular Shells with Sealed Screw-holes manufactured by Zimmer, Austin, Texas
FDA Recall
Terminated
·Centerpulse Orthopedics, Inc·Product code LZO·September 30, 2003
Accolade C CS These devices are modular components of a total hip system. These femoral stems are intended for use with femoral heads and acetabular components in primary or revision total hip arthroplasty.
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code LZO·November 13, 2008
Restoration Modular Conical Distal Bowed Stem. 14 mm x 195 mm; Stryker Orthopaedics. Intended to be used for primary or revision total hip arthroplasty as well as in the presence of sever proximal bone loss.
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code LZO·June 26, 2009
Restoration Modular Hip System; Proximal Cone Body; 23 mm +0 mm (STD); Not for use with + 16 V40 femoral Head. For Cementless Use Only. Stryker Orthopaedics. Intended to be used for primary or revision total hip arthroplasty as well as in the presence of sever proximal bone loss.
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code LZO·June 26, 2009
Restoration Modular Calcar Body, 27 mm +10 mm; Stryker Orthopaedics. Intended to be used for primary or revision total hip arthroplasty as well as in the presence of sever proximal bone loss.
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code LZO·June 26, 2009
Restoration Modular Hip System; Proximal Cone Body; 23 mm +20 mm; Not for use with + 16 V40 femoral Head. For Cementless Use Only. Stryker Orthopaedics. Intended to be used for primary or revision total hip arthroplasty as well as in the presence of sever proximal bone loss.
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code LZO·June 26, 2009