Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

1,565 results found for sterilization Page 20 of 63
Integra LifeSciences Corp.
Class II Terminated
C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
Reason: The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual stat...
Z-0631-2020 December 18, 2019 Plainsboro, NJ
Integra LifeSciences Corp.
Class II Terminated
C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
Reason: The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual stat...
Z-0641-2020 December 18, 2019 Plainsboro, NJ
Integra LifeSciences Corp.
Class II Terminated
C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
Reason: The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual stat...
Z-0625-2020 December 18, 2019 Plainsboro, NJ
Integra LifeSciences Corp.
Class II Terminated
C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
Reason: The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual stat...
Z-0654-2020 December 18, 2019 Plainsboro, NJ
Integra LifeSciences Corp.
Class II Terminated
C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
Reason: The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual stat...
Z-0634-2020 December 18, 2019 Plainsboro, NJ
Integra LifeSciences Corp.
Class II Terminated
C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
Reason: The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual stat...
Z-0645-2020 December 18, 2019 Plainsboro, NJ
Integra LifeSciences Corp.
Class II Terminated
C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
Reason: The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual stat...
Z-0618-2020 December 18, 2019 Plainsboro, NJ
Integra LifeSciences Corp.
Class II Terminated
C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
Reason: The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual stat...
Z-0644-2020 December 18, 2019 Plainsboro, NJ
Integra LifeSciences Corp.
Class II Terminated
C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
Reason: The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual stat...
Z-0652-2020 December 18, 2019 Plainsboro, NJ
Integra LifeSciences Corp.
Class II Terminated
C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
Reason: The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual stat...
Z-0636-2020 December 18, 2019 Plainsboro, NJ
Integra LifeSciences Corp.
Class II Terminated
C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
Reason: The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual stat...
Z-0614-2020 December 18, 2019 Plainsboro, NJ
Integra LifeSciences Corp.
Class II Terminated
C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
Reason: The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual stat...
Z-0632-2020 December 18, 2019 Plainsboro, NJ
Integra LifeSciences Corp.
Class II Terminated
C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
Reason: The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual stat...
Z-0642-2020 December 18, 2019 Plainsboro, NJ
Integra LifeSciences Corp.
Class II Terminated
C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
Reason: The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual stat...
Z-0647-2020 December 18, 2019 Plainsboro, NJ
Integra LifeSciences Corp.
Class II Terminated
C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
Reason: The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual stat...
Z-0623-2020 December 18, 2019 Plainsboro, NJ
Integra LifeSciences Corp.
Class II Terminated
C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
Reason: The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual stat...
Z-0635-2020 December 18, 2019 Plainsboro, NJ
Integra LifeSciences Corp.
Class II Terminated
C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
Reason: The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual stat...
Z-0616-2020 December 18, 2019 Plainsboro, NJ
Integra LifeSciences Corp.
Class II Terminated
C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
Reason: The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual stat...
Z-0633-2020 December 18, 2019 Plainsboro, NJ
Integra LifeSciences Corp.
Class II Terminated
C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
Reason: The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operator s manual sta...
Z-0613-2020 December 18, 2019 Plainsboro, NJ
Integra LifeSciences Corp.
Class II Terminated
C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
Reason: The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual stat...
Z-0643-2020 December 18, 2019 Plainsboro, NJ
Integra LifeSciences Corp.
Class II Terminated
C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
Reason: The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual stat...
Z-0649-2020 December 18, 2019 Plainsboro, NJ
Steris Corporation
Class II Terminated
Eagle 3000 Sterilizer, small steam sterilizer. Product Usage: The Eagle 3000 Small Sterilizer is designed for sterilization of certain materials used in healthcare facilities, and are available in two...
Reason: Potential for the incorrect pressure safety valve being included in the Preventive Maintenance (PM) kit for the 3000 Small Sterilizers.
Z-0604-2020 December 11, 2019 Mentor, OH
Integra LifeSciences Corp.
Class II Terminated
Integra Jarit GEMINI CLAMP 9 1/4 inch - used in vascular and cardiothoracic procedures used for clamping and occluding vessels. Cat. #140-332
Reason: A small crack at the box lock corner may after multiple cleaning and sterilization cycles produce an increased risk of corrosion, weakening the instrument and resulting in prematur...
Z-2435-2019 September 11, 2019 Plainsboro, NJ
Ad-Tech Medical Instrument Corporation
Class II Terminated
LSB Style Anchor Bolt. Labeled with the following parts: 13mm anodized anchor bolt body with anchor bolt cap containing a blue gasket and silicone cap, 21mm anodized anchor bolt body with anchor...
Reason: On June 12, 2019 Ad-Tech was made aware that on three different occasions between March 1, 2019 and May 31, 2019 Ad-Tech personnel have distributed non-sterile anchor bolt parts to...
Z-2204-2019 August 14, 2019 Oak Creek, WI
Zimmer Biomet, Inc.
Class II Terminated
Comprehensive Reverse Shoulder Instrument Case Total (Outer Case Vault Only), Item Number 595510
Reason: Lack of an adequate sterilization validation.
Z-1961-2019 July 24, 2019 Warsaw, IN