February 7, 2024Medical DevicesFDA
Olympus Corporation of the Americas recalls EZDilate Fixed Wire Balloon 8.5-9.5-10.5. Indicated for endoscopic dilation of strictures of the esophagus in adults and
Hazard: Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure.
February 7, 2024Medical DevicesFDA
Olympus Corporation of the Americas recalls EZDilate Fixed Wire Balloon 6-7-8. Indicated for endoscopic dilation of strictures of the esophagus in adults and adoles
Hazard: Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure.
February 7, 2024Medical DevicesFDA
TriMed Inc. recalls Volar Bearing Plate. REF: VBEAL-3-7N, VBEAL-5-7N, VBEAL-3-7S, VBEAL-5-7S, VBEAL-7-7S, VBEAL-3-7W, VBEAL-5-7W, VBEAR-
Hazard: Plates, part of a wrist fixation system, are affixed during surgery with bearings that may pop out from distal peg holes.
February 7, 2024Medical DevicesFDA
AtriCure, Inc. recalls Packaged, Tank Hose Assembly CMA-US, Product Catalog Number A001056
Hazard: AtriCure has identified certain lots of tank hose assemblies where a second-tier supplier provided incorrect tank hose assemblies. These tank hose assemblies were provided with an outer sheathing that does not have required pin perforations and the inner tube of the hose is not the correct material.
February 7, 2024Medical DevicesFDA
AtriCure, Inc. recalls Cryo Module Accessories Domestic CMA-OUS, Product Catalog Number A001053
Hazard: AtriCure has identified certain lots of tank hose assemblies where a second-tier supplier provided incorrect tank hose assemblies. These tank hose assemblies were provided with an outer sheathing that does not have required pin perforations and the inner tube of the hose is not the correct material.
February 7, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls TIBIAL BEARING INSERT SERIES P-S I ASSY Intended for knee replacement Product Number: 7291-0324
Hazard: Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
February 7, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls PS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee replacement Product Number: 6742-1-416
Hazard: Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
February 7, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls PS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee replacement Product Number: 6742-1-413
Hazard: Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
February 7, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls PS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee replacement Product Number: 6742-1-411
Hazard: Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
February 7, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls DUR PCA MTK REV INS RT Intended for knee replacement Product Number: 6728-2-711
Hazard: Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
February 7, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls DUR PCA MTK REV INS RT Intended for knee replacement Product Number: 6728-2-709
Hazard: Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
February 7, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls DUR PCA MTK REV INS LFT Intended for knee replacement Product Number: 6728-2-611
Hazard: Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
February 7, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls DUR PCA MTK REV INS LFT Intended for knee replacement Product Number: 6728-2-609
Hazard: Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
February 7, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls DURATION PLASTIC PATELLA-DURACON Intended for knee replacement Product Number: 6642-2-200
Hazard: Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
February 7, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls DURATION A-P LIPPED TIB.INSERT-DURAC Intended for knee replacement Product Number: 6642-1-911
Hazard: Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
February 7, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls DURATION A-P LIPPED TIB.INSERT-DURAC Intended for knee replacement Product Number: 6642-1-709
Hazard: Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
February 7, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls LARGE PRIMARY REV.TIB.INSERT- DURACON Intended for knee replacement Product Number: 6637-4-231
Hazard: Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
February 7, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls PRIMARY REV.TIB.INSERT-DURACON Intended for knee replacement. Product Number: 6637-4-031
Hazard: Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
February 7, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement. Product Number: 6637-0-931
Hazard: Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
February 7, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement Product Number: 6637-0-928
Hazard: Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
February 7, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement Product Number: 6637-0-831
Hazard: Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
February 7, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls LEFT SMALL-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement. Product Number: 6637-0-631
Hazard: Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
February 7, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls LEFT X-LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement. Product Number: 6637-0-328
Hazard: Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
February 7, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls LEFT LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement Part Number: 6637-0-231
Hazard: Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
February 7, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls LEFT LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement Part Number: 6637-0-228
Hazard: Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
February 7, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls LEFT SMALL-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement Part Number: 6637-0-028
Hazard: Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
February 7, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls P7 32MM 1O DEGREE +4MM INSERT Intended for knee replacement Part Number: 6302-6-307
Hazard: Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
February 7, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls P7 28MM 10 DEGREE +4MM INSERT Intended for knee replacement Part Number: 6302-6-107
Hazard: Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
February 7, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls HOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT Intended for knee replacement Part Number: 620-00-32J
Hazard: Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
February 7, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls HOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT Intended for knee replacement Part Number: 620-00-32J
Hazard: Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.