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Recall Observatory FDA recall evidence

Core noun

Device recall evidence

Joined enrichment rows that support device recall linkage and root-cause wording.

Indexed record set

39,516 evidence rows

Page 1516 of 1581

Evidence Product Join Root cause
device-recall:cfres:169803 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. Official recall number · Z-0733-2019 Under Investigation by firm
device-recall:cfres:169749 U by Kotex¿ Sleek¿, Regular Tampons, 3 Count Official recall number · Z-0751-2019 Under Investigation by firm
device-recall:cfres:167857 Affixus Hip Fracture Nail Left 125 Deg 9x165mm, Item Number 816709165 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures of the proximal femur. Official recall number · Z-0450-2019 Mixed-up of materials/components
device-recall:cfres:168866 ARTIS Q biplane with Material 10848282- - a Angiographic x-ray system Product Usage: Artis zee is a dedicated angiography system developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis zee includes cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis zee can also support the acquisition of position triggered imaging for spatial data synthesis. Official recall number · Z-0458-2019 Device Design
device-recall:cfres:167482 R&D systems, a bio-techne brand Human Total 25-OH Vitamin D IVD ELISA Kit, REF RDKAP1971 Official recall number · Z-0410-2019 Unknown/Undetermined by firm
device-recall:cfres:168165 Medtronic CareLink 2090 Programmer Official recall number · Z-0406-2019 Software design
device-recall:cfres:167624 OviTex Reinforced BioScaffold 10x12cm, Part Number F10254-1012G Official recall number · Z-0417-2019 Other
device-recall:cfres:168358 CyberKnife M6, Part Number 054000-004 The CyberKnife M6 Systems are indicated for treatment planning and image guided stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. Official recall number · Z-0408-2019 Process control
device-recall:cfres:167630 OviTex 1S Reinforced BioScaffold 6x10cm, Part Number F10256-0610G Official recall number · Z-0422-2019 Other
device-recall:cfres:168095 DT Medical -Hintermann Series H3 Poly Inlay, Size 3 5mm Part Number: 300305 components are prostheses for a mobile bearing ankle joint. Official recall number · Z-0402-2019 Packaging process control
device-recall:cfres:168103 DT Medi Tech Hintermann Series Talar Implant LEFT-SIZE 4 Part Number: 302114 components are prostheses for a mobile bearing ankle joint. Official recall number · Z-0403-2019 Packaging process control
device-recall:cfres:168872 Laser Fiber Assy-Single Use-LFS-272-RT-0.22NA-SMA905- Slim Extension Sleeve Silver-Sterile ETO- Private label: SU-200-RT SmartScope Packaging. The Laser peripherals bare laser fibers, ENT fibers and Endoprobes are intended for use in laser surgical procedure for cutting, coagulating, or vaporizing in any soft tissue application for which compatible Nd: YAG, Ho: YAG, KTP and Diode lasers have been cleared. Official recall number · Z-0577-2019 Packaging
device-recall:cfres:169030 Covidien Emprint Short Percutaneous Antenna with Thermosphere Technology, Material CA15L2 intended for use in percutaneous, laparoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of nonresectable liver tumors. Official recall number · Z-0626-2019 Nonconforming Material/Component
device-recall:cfres:169039 Optiflux F160NR Capillary High Flux Dialyzer Single Use Only, Product Code 0500316E Official recall number · Z-0658-2019 Other
device-recall:cfres:169037 ST AIA-PACK Homocysteine (HCY) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of homocysteine in human serum, heparinized plasma or EDT A plasma on TOSOH AIA System Analyzers. Homocysteine measurements are used in the diagnosis and treatment of hyperhomocysteinemia or homocysteinuria. Official recall number · Z-0675-2019 Device Design
device-recall:cfres:167791 Thermoset Room Temperature Closed Loop Injectate Delivery System. 1 unit per Cavity #3 Cavity Deep/20 pieces per case R1-6090 Official recall number · Z-0661-2019 Equipment maintenance
device-recall:cfres:168908 Genesys Diluent Reagent, REF 01-03-0019 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use only. Official recall number · Z-0624-2019 No Marketing Application
device-recall:cfres:169116 Alinity i Estradiol Reagent Kit, List Number 07P5020 Official recall number · Z-0667-2019 Nonconforming Material/Component
device-recall:cfres:169229 Protexis Neoprene Surgical Glove, Size 8.5 This powder-free sterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. Official recall number · Z-0637-2019 Labeling mix-ups
device-recall:cfres:168971 VITROS¿ 3600 Immunodiagnostic System, Version 3.3.1 & below For use in the in vitro quantitative measurement of a variety of analytes of clinical interest in certain biological fluids (depending on the analyte) such as serum, plasma, urine and cerebrospinal fluid. Official recall number · Z-0652-2019 Software Manufacturing/Software Deployment
device-recall:cfres:169996 Arthrex Suture Anchor, Nano Corkscrew FT (consists of an anchor pre-loaded on a handled inserter including suture, with needles.) Part Number AR-1317FT Product Usage: Soft tissue fixation to bone in the hand and wrist Official recall number · Z-0724-2019 Process control
device-recall:cfres:169713 ddRCombi Plus FP, Model Number 8.2000.0070.0 (US Version), 8.2000.0060.0 (Europe Version) The ddRCombi Plus FP is a fully digital, multifunctional X-ray system that allows the direct digitization of X-ray information without use of cassettes or other media. It can perform all applications in orthopedics and trauma as well as pulmonary imaging. Official recall number · Z-0697-2019 Component design/selection
device-recall:cfres:169827 DX-D 600 DIRECT RADIOGRAPHY SYSTEM Product Usage: The DX-D 600 system is a ceiling mounted General Radiography X-Ray imaging system used in hospitals, clinics and medical practices by physicists, radiographers and radiologists to make, process and view static X-Ray radiographic images of the skeleton (including skull, spinal column and extremities), chest, abdomen and other body parts on adult, pediatric or neonatal patients. Official recall number · Z-0692-2019 Software design
device-recall:cfres:169778 MED-RX POLYURETHANE FEEDING TUBE For Pediatric Use with Orange Radioplaque Stripe and Enteral Connector, 6.5Fr X 24" (60cm), REF 54-2465-R Product Usage: A Nasogastric/Oralgastric enteral feeding tube. The MED-RX Feeding Tube is intended to be used for nasogastric/oralgastric enteral feeding as directed by a physician. Official recall number · Z-0725-2019 Under Investigation by firm
device-recall:cfres:170001 Siemens Biograph Horizon PET/CT System, Product Usage: The Siemens Biograph systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. Official recall number · Z-0707-2019 Device Design

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