EBI, LLC - Biomet OrthoPak Noninvasive Bone Growth Stimulator System - Class 2 Recall
Biomet OrthoPak Non-invasive Bone Growth Stimulator System-Indicated for the treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones. Part Number: 1067718 (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 24, 2024 Category: Medical Devices Source Type: alerts
EBI, LLC - Biomet OrthoPak Noninvasive Bone Growth Stimulator System - Class 2 Recall
Biomet SpinalPak Non-invasive Spine Fusion Stimulator System- Indicated for the treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones, Part Number: 1067716 (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 24, 2024 Category: Medical Devices Source Type: alerts
EBI, LLC - The Biomet OrthoPak Noninvasive Bone Growth Stimulator System - Class 2 Recall
20" Lead Wires, Replacement Part Number: 1067724-2 (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 24, 2024 Category: Medical Devices Source Type: alerts
EBI, LLC - The Biomet OrthoPak Noninvasive Bone Growth Stimulator System - Class 2 Recall
48" Lead Wires, Replacement Part Number: 1067724-4 (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 24, 2024 Category: Medical Devices Source Type: alerts
Biomet, Inc. - Vanguard Anterior Stabilized Tibial Bearing - Class 2 Recall
Vanguard Knee System AS Tibial Bearing / DCM ArCom, 12 MM X 75 MM; Model Number 189082. The product is placed into a foil pouch with protective packaging in the form of a polyurethane bag, and sealed closed (inner barrier). The inner barrier is then placed into a PETG tray and sealed with Tyvek lid stock (outer barrier). The sealed double barrier system is placed into a paperboard carton with an IFU and label/indicator dots applied to the carton. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 23, 2024 Category: Medical Devices Source Type: alerts
Alcon Research, LLC - Alcon Custom Pak - Class 2 Recall
Various Alcon Custom Paks Surgical Procedure Pack containing Oasis 27Ga Chang Hydrodissection Cannulas. These Custom Paks are surgical procedure packs used by ophthalmic surgeons in a variety of ophthalmic surgeries. The Custom Pak is a collection of various ophthalmic surgical instruments and necessary materials. Below are the various Alcon Customer Paks and Pak REF Numbers: 0515-66 ELMENDORF AFB CATARACT 3RD MED CTR 0752-74 CATARACT V A MED CTR 1119-82 DR DAVID B LEACH PALOUSE SURGERY CENTER 11401-13 CATARACT SUTTER SOLANO MED CTR 11910-32 DAVISON-SAGGAU CATARACT WOLFE EYE SURGER 11912-26 30 DEG CATARACT BASE PACK WOLFE ...
Source: Medical Device Recalls - April 23, 2024 Category: Medical Devices Source Type: alerts
SEASPINE ORTHOPEDICS CORPORATION - SeaSpine Mariner RDX System - Class 2 Recall
Mariner RDX Polyaxial Head, REF: MX1-000020; Mariner RDX Extended Polyaxial Head, REF: MX1-000030; Mariner RDX Deformity Head, REF: MX1-000040; Mariner RDX Extended Deformity Head, REF: MX1-000050; Mariner RDX Trauma Head, REF: MX1-000060; Mariner RDX Extended Trauma Head. REF: MX1-000070, part of Mariner RDX Alpha Instruments and Implants, REF: AMRDX and Mariner RDX TD Alpha Implants, REF: AMRDXTD, which are pedicle screw systems. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 23, 2024 Category: Medical Devices Source Type: alerts
Zimmer, Inc. - NexGen CRFlex Porous Femur - Class 2 Recall
NexGen CR-Flex Femoral Component, Size E and Size E Minus (E-). Component of the NexGen CR-Flex Porous Femur System. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 23, 2024 Category: Medical Devices Source Type: alerts
Ion Beam Applications S.A. - ProteusPLUS and ProteusONE - Class 2 Recall
IBA Proton Therapy System - PROTEUS 235, PTS-10 versions, PTS-11 versions, and PTS-12 versions. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 20, 2024 Category: Medical Devices Source Type: alerts
Parker Laboratories, Inc. - Redux Electrolyte Creme - Class 2 Recall
Redux Electrolyte Creme, Product Ref. 66-04. Highly conductive electrolyte creme. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 20, 2024 Category: Medical Devices Source Type: alerts
SonarMed Inc - SonarMed Air Wave - Class 1 Recall
AW-M0001 SONARMED MONITOR. Used in conjunction with SonarMed Acoustic Sensors for airway monitoring. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 20, 2024 Category: Medical Devices Source Type: alerts
Abbott Molecular, Inc. - Abbott Alinity m System - Class 2 Recall
Alinity m System, Part Number: 08N53-002 (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 20, 2024 Category: Medical Devices Source Type: alerts
Siemens Medical Solutions USA, Inc. - ACUSON Juniper Diagnostic Ultrasound System - Class 2 Recall
ACUSON Juniper Diagnostic Ultrasound System, REF: 11335791, and ACUSON Juniper Select Diagnostic Ultrasound System, REF: 11653093, running software version VA10x with DICOM SR Cardiac option, from VB10A to VB10G, VB11A, VB11B, VB30B and VB30C (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 20, 2024 Category: Medical Devices Source Type: alerts
Siemens Medical Solutions USA, Inc. - ACUSON Maple Diagnostic Ultrasound System - Class 2 Recall
ACUSON Maple Diagnostic Ultrasound System, REF: 11711750, ACUSON Maple Select, REF: 11711779, running software version VA10A (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 20, 2024 Category: Medical Devices Source Type: alerts
Siemens Medical Solutions USA, Inc. - ACUSON Redwood 1.0 Diagnostic Ultrasound System - Class 2 Recall
ACUSON Redwood 1.0 Diagnostic Ultrasound System, REF: 11503314, running software version VA10A to VA10G (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 20, 2024 Category: Medical Devices Source Type: alerts
