74 results
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11ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
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Comprehensive HHR Tess Cleat, Item Nos. 110260 110261 110262 110263 Product Usage: N/A
FDA Recall
Terminated
·Zimmer Biomet, Inc.·Product code NA·August 21, 2019
Comprehensive HHR Tess Cleat, Item Nos. 110260 110261 110262 110263 Product Usage: N/A
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·December 4, 2019
smith&nephew BHR SQUARE HEADED NAIL, REF CATALOG NUMBER 999908. For use during orthopedic surgery.
FDA Recall
Terminated
·Smith & Nephew Orthopaedics Ltd. (Aurora) Aurora, Spa Park Harrison Way Leamington Spa United Kingdom·Product code NXT·July 14, 2021
smith&nephew BHR SQUARE HEADED NAIL, REF CATALOG NUMBER 999908. For use during orthopedic surgery.
FDA Enforcement
Class II
·Terminated·Smith & Nephew Orthopaedics Ltd. (Aurora)·August 18, 2021
Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING DYSPLASIA CUP W/IMPACTOR, REF Numbers: 74120246 (46 MM), 74122248 (48 MM), 74120250 (50 MM), 74122252 (52 MM), 74120254 (54 MM) Product Usage: Hip joint prosthesis
FDA Enforcement
Class II
·Terminated·Smith & Nephew, Inc.·September 16, 2015
Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING FEMORAL HEAD, STERILE R, Rx only, REF Numbers: 74121138 (38 MM), 74123140 (40 MM), 74121142 (42 MM), 74123144 (44 MM), 74121146 (46 MM). Product Usage: Hip joint prosthesis
FDA Enforcement
Class II
·Terminated·Smith & Nephew, Inc.·September 16, 2015
Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING ACETABULAR CUP W/IMPACTOR, REF Numbers: 74120144 (44 MM), 74120146 (46 MM), 74122146 (46 MM), 74122148 (48 MM), 74120148 (48 MM), 74120150 (50 MM), 74122150 (50 MM), 74122152 (52 MM), 74120152 (52 MM), 74120154 (54 MM) Product Usage: Hip joint prosthesis
FDA Enforcement
Class II
·Terminated·Smith & Nephew, Inc.·September 16, 2015
Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup W/ Impactor, 46 mm cup Ref.: 74120146
FDA Recall
Terminated
·Smith & Nephew Inc·Product code LXH·March 13, 2007
Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup W/ Impactor, 58 mm cup Ref.: 74120158
FDA Recall
Terminated
·Smith & Nephew Inc·Product code LXH·March 13, 2007
Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup W/ Impactor, 56 mm cup Ref.: 74120156
FDA Recall
Terminated
·Smith & Nephew Inc·Product code LXH·March 13, 2007
Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup W/ Impactor, 50 mm cup Ref.: 74120150
FDA Recall
Terminated
·Smith & Nephew Inc·Product code LXH·March 13, 2007
Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup W/ Impactor, 60 mm cup Ref.: 74120160
FDA Recall
Terminated
·Smith & Nephew Inc·Product code LXH·March 13, 2007
BrightView X are gamma cameras; Designed for single or dual detector nuclear imaging.
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code KPS·December 17, 2015
BrightView are gamma cameras; Designed for single or dual detector nuclear imaging.
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code KPS·December 17, 2015
Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING DYSPLASIA CUP W/IMPACTOR, REF Numbers: 74120246 (46 MM), 74122248 (48 MM), 74120250 (50 MM), 74122252 (52 MM), 74120254 (54 MM) Product Usage: Hip joint prosthesis
FDA Recall
Terminated
·Smith & Nephew, Inc.·Product code NXT·June 3, 2015
BrightView XCT & BrightView XCT Upgrade, gamma cameras; For Single Proton Emission Computed Tomography.
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code KPS·December 17, 2015
Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING FEMORAL HEAD, STERILE R, Rx only, REF Numbers: 74121138 (38 MM), 74123140 (40 MM), 74121142 (42 MM), 74123144 (44 MM), 74121146 (46 MM). Product Usage: Hip joint prosthesis
FDA Recall
Terminated
·Smith & Nephew, Inc.·Product code NXT·June 3, 2015
Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING ACETABULAR CUP W/IMPACTOR, REF Numbers: 74120144 (44 MM), 74120146 (46 MM), 74122146 (46 MM), 74122148 (48 MM), 74120148 (48 MM), 74120150 (50 MM), 74122150 (50 MM), 74122152 (52 MM), 74120152 (52 MM), 74120154 (54 MM) Product Usage: Hip joint prosthesis
FDA Recall
Terminated
·Smith & Nephew, Inc.·Product code NXT·June 3, 2015
BrightView X are gamma cameras; Designed for single or dual detector nuclear imaging.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·March 9, 2016
Alaris Pump Module, Model 8100, serviced/repaired by Step-Har Medical with an impacted bezel repair part
FDA Enforcement
Class I
·Terminated·STEP-HAR MEDICAL LLC·May 19, 2021