Core noun
Device recall evidence
Joined enrichment rows that support device recall linkage and root-cause wording.
Indexed record set
39,516 evidence rows
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- Evidence
- device-recall:cfres:109709
- Product
- SoftLab with SA INST versions: 3.1.6.12, 4.0.1.26-4.0.1.32, 4.0.2.21-4.0.2.51, and 4.0.3.5-4.0.3.13. Product UsageSoftLab is a laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained, and experienced personnel. SoftLab enables the user to handle data-processing and laboratory activities, for the purpose of storing, managing, querying, and reporting laboratory data.
- Join
- Official recall number ·
Z-2143-2012 - Root cause
- Software design
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- Evidence
- device-recall:cfres:111138
- Product
- Maquet Getinge Group Operating Table System Magnus Carbon-Fibre Table Top Version 1180.16 The carbon-fibre MAGNUS table top (1180-16XX) serves to support and position patients for surgical procedures (e.g. cardiovascular surgery) and interventional examination immediately before, during and after the surgical phase. The table top is radiotranslucent and enables intraoperative use of X-ray equipment.
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- Official recall number ·
Z-2108-2012 - Root cause
- Device Design
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- Evidence
- device-recall:cfres:110838
- Product
- Beekley A-Spots Floral Skin Markers -Order Number: 751 Product Usage: Mammography Skin Markers for marking: moles, scars, palpable masses or areas of concern
- Join
- Official recall number ·
Z-2110-2012 - Root cause
- Unknown/Undetermined by firm
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- Evidence
- device-recall:cfres:111059
- Product
- Equinoxe Anatomic Replicator Plate Intended for Primary and Reverse Total Shoulder Arthroplasty
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- Official recall number ·
Z-2115-2012 - Root cause
- Labeling False and Misleading
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- Evidence
- device-recall:cfres:108648
- Product
- Integra¿ Advansys Medial Lisfranc Plate (MLP), Integra, 311 Enterprise Drive, Plainsboro, NJ 08536 The Advansys plates are intended for bone fixation such as: Arthrodesis of the 1st metatarsocuneiform joint to reposition and stabilize a metatarsus primus varus, Lisfranc arthrodesis, Mono or bi-cortical osteotomies or fractures near the 1st metatarsocuneiform joint.
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- Official recall number ·
Z-2123-2012 - Root cause
- Labeling design
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- Evidence
- device-recall:cfres:109104
- Product
- CIVCO VirtuTRAX Instrument Navigator, Reusable non-sterile general purpose driveBAY, trakSTAR, electromagnetic sensor (8mm) with VirtuTRAX Instrument navigator and (8.9 tapered to 1.3 x 147cm) telescopically-folded CIV-Flex sensor covers (5), Ref. 610-1080. The firm name on the label is CIVCO, Kalona, IA. The kit contains sensor component part number 410-240. The general purpose sensor within the kit is intended to provide physicians with tools for electromagnetic tracking of instruments with respect to image data. The sensors are designed to attach to custom reusable tracking bracket for leading transducers and other medical devices
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- Official recall number ·
Z-1956-2012 - Root cause
- Component design/selection
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- Evidence
- device-recall:cfres:109900
- Product
- PathFinder NXT Pivoting Percutaneous Rod Holder This device is an instrument used during orthopedic surgery. The intended use of the pivoting percutaneous rod holder is to attach to the rod to facilitate rod insertion, positioning, and orientation through the extender sleeves, under the fascia. The rod is secured to the holder by tightening a captive set screw against the rod end in the tip of the holder using the set screw driver. After positioning the rod and securing at least one pedicle screw closure top against the implanted rod, the holder is removed from the rod end by loosening the captive set screw with the set screw driver.
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- Official recall number ·
Z-1933-2012 - Root cause
- Device Design
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- Evidence
- device-recall:cfres:109504
- Product
- Alere Triage BNP PN 98000XR Intended to be used as an aid in the diagnosis and assessment of severity of congestive heart failure (also referred to as heart failure).
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- Official recall number ·
Z-1931-2012 - Root cause
- Process design
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- Evidence
- device-recall:cfres:109096
- Product
- CIVCO VirtuTRAX Instrument Navigator, Reusable non-sterile general purpose driveBAY, trakSTAR, electromagnetic sensor (8mm) with VirtuTRAX instrument navigator and (8.9 tapered to 1.3 x 147cm) telescopically-folded CIV-Flex sensor covers (5), Ref. 5350925. The firm name on the label is CIVCO, Kalona, IA. The kit contains sensor component part number 410-240. The general purpose sensor within the kit is intended to provide physicians with tools for electromagnetic tracking of instruments with respect to image data. The sensors are designed to attach to custom reusable tracking bracket for leading transducers and other medical devices
- Join
- Official recall number ·
Z-1952-2012 - Root cause
- Component design/selection
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- Evidence
- device-recall:cfres:111072
- Product
- PHADIA Varelisa Cardiolipin IgM Cardiolipin autoantibody immunological test system (IgM class antibodies)
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- Official recall number ·
Z-2285-2012 - Root cause
- Labeling Change Control
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- Evidence
- device-recall:cfres:111224
- Product
- Product is labeled in part: "***MEDLINE***Standard PTFE Coated Needle with Extended Insulation 2.75 (6.99cm) Length***Reorder: ES0013M***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of Medline Industries, Inc. 1-800-MEDLINE***Mundelein, IL 60060 USA Made in USA.***" Part # ES0013M -- Lot # 042209-02 Product Usage: Intended for cutting and coagulation of soft tissue.
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- Official recall number ·
Z-2291-2012 - Root cause
- Process control
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- Evidence
- device-recall:cfres:109643
- Product
- Product is labeled in part: "***MEDLINE***Extended PTFE Needle 6.5" (16.51cm) Length***Reorder: ES0016***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of Medline Industries, Inc. 1-800-MEDLINE***Mundelein, IL 60060 USA Made in USA.***" Part # ES0016 -- Lot #: 030608-01 and 121808-19. Product Usage: Intended for cutting and coagulation of soft tissue.
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- Official recall number ·
Z-2286-2012 - Root cause
- Process control
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- Evidence
- device-recall:cfres:109613
- Product
- Product is labeled in part: "***OPTETRAK***TIBIAL TRAY***TRAPEZOID CEMENTED***Ti Alloy*** SIZE 1F/1T, 2F/1T***FOR CEMENTED USE ONLY***Exactech, Gainesville, FL 32653-1630.***REF 204-04-21***". The Optetrak Comprehensive Knee Systems are indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems. They are also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present. In the USA, the Optetrak Comprehensive Knee System is indicated for cemented use only.
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- Official recall number ·
Z-2070-2012 - Root cause
- Labeling mix-ups
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- Evidence
- device-recall:cfres:109892
- Product
- PrepStain Upgrade Kit: 1.3.0.3/1.2 DiTi Cone. The PrepStain System is a liquid-based thin layer cell preparation process. The PrepStain System produces SurePath Slides that are intended for use in the screening and detection of cervical cancer, pre-cancerous lesions, atypical cells and all other cytologic categories as defined by The Bethesda System for Reporting Cervical/Vaginal Cytology Diagnoses. The 1.2 DiTi is the tip on the PrepStain to which a pipette tip attaches and dispenses patient samples onto a glass microscope slide.
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- Official recall number ·
Z-2086-2012 - Root cause
- Nonconforming Material/Component
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- Evidence
- device-recall:cfres:110871
- Product
- IMPAX CV Reporting The Results Management (RM)/IMPAX CV reporting component facilitates the quick, effective creating of digital structured reports for : adult catheterization and echocardiography, pediatric echocardiography, congenital heat disease, nuclear cardiology and non-invasive vascular disease management. This webb-based application allows cardiology departments to view, edit and sign the structured reports.
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- Official recall number ·
Z-2069-2012 - Root cause
- Error in labeling
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- Evidence
- device-recall:cfres:110697
- Product
- ABG II Modular Hip Stem Stryker Howmedica Osteonics Corp. Mahwah, NJ 07430 Stryker Ireland Carrigtwohill Industrial Estate, Carrigtwohill County Cork, Ireland. The ABG II Modular range of implants is constituted of 8 right stems and 8 left stems. The necks are made of GADS Vitallium, a proprietary Co Cr alloy that Stryker has developed. GADS stands for Gas Atomized Dispersion Strengthened. IT is a Co Cr alloy that is a corrosion resistant and demonstrates qualities of improved fatigue strength (with respect to regular Co Cr alloy). Neck Range - The ABG II modular neck range is composed of 10 reversible neck implants. There are different options in terms of length, version and neck angle. The AG II Modular necks come in two different lengths: 28 mm (short) and 36 mm (long). The necks are offered in two version angles ; 0 and 7. The 0 and 7 necks are available in 125, 130 and 135 neck angles.
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- Official recall number ·
Z-2089-2012 - Root cause
- Device Design
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- Evidence
- device-recall:cfres:110982
- Product
- KIT,DISPOSABLE ACCESSORY,4ARM,IS3000,5 PACK; Product Usage: The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures using the da Vinci Surgical Systems.
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- Official recall number ·
Z-2105-2012 - Root cause
- Nonconforming Material/Component
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- Evidence
- device-recall:cfres:110688
- Product
- BridgePoint Medical, Stingray Catheter, REF M - 1000, Sterilized with Ethylene Oxide Gas, Prescription Only, Manufacturer BridgePoint Medical Inc. 13355 10th Ave N, Suite 110, Plymouth, MN 55441. Stingray" Catheters are intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic coronary lesions (including chronic total occlusions) prior to PTCA or stent intervention. When used as part of the BridgePoint Medical System, the Stingray Catheter is intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic coronary lesions (including chronic total occlusions [CTOs]) prior to PTCA or stent intervention. .
- Join
- Official recall number ·
Z-2074-2012 - Root cause
- Process control
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- Evidence
- device-recall:cfres:111312
- Product
- PopLok Punch labeled in part: "PKL-35M***3.5mm***QTY 1***PopLok Punch***ConMed Linvatec Biomaterials, Ltd. Hermiankatu 6-8L 33720 Tampere, FINLAND***Rx Only***ConMed Linvatec 11311 Concept Blvd Largo, FL 33773-4908 USA***Made in USA***" Intended Use: Bone Punch.
- Join
- Official recall number ·
Z-2151-2012 - Root cause
- Process change control
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- Evidence
- device-recall:cfres:111260
- Product
- IMPAX Cardiovascular (CV) Reporting Reporting tool used for structured reporting and structured report outputs (including XML style sheet customization and PDF)
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- Official recall number ·
Z-2184-2012 - Root cause
- Software change control
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- Evidence
- device-recall:cfres:110440
- Product
- Radiological Image Processing System The system is an aid to locate anatomical structures during open or percutaneous surgical procedures. It is indicated for use in medical conditions that may benefit from the use of stereotactic surgical technique. The system provides a reference to rigid anatomical structures such as sinus, skull, long bone, or vertebra, which are visible on medical images such as CS, MR, or X-ray.
- Join
- Official recall number ·
Z-2136-2012 - Root cause
- Software design
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- Evidence
- device-recall:cfres:111555
- Product
- The ABL software version 6.12 for the ABL800 and ABL700 analyzer. The analyzers are intended for the in Vitro testing of: -Samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl-, cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) -Samples of expired air for the parameters pO2 and pCO2 -Pleura samples for the pH parameter. The ABL software version 6.12 for the ABL800 and ABL700 analyzer. The analyzers are intended for the in Vitro testing of: -Samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl-, cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) -Samples of expired air for the parameters pO2 and pCO2 -Pleura samples for the pH parameter.
- Join
- Official recall number ·
Z-2163-2012 - Root cause
- Software design
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- Evidence
- device-recall:cfres:110835
- Product
- Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with two #2 sutures (COBRAID-blue, COBRAIDblack), sterile Part Number: 72202896 Product Usage: intended for use for the reattachment of soft tissue to bone
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- Official recall number ·
Z-2167-2012 - Root cause
- Device Design
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- Evidence
- device-recall:cfres:109553
- Product
- Vygon VY(TM)Flush Heparin Lock Flush Syringes, 10 Units per mL, 3mL in a 10mL Flush Syringe, 30 syringes per box, Rx only Prefilled syringes are used to maintain the patency of indwelling catheter lumens
- Join
- Official recall number ·
Z-1798-2012 - Root cause
- Nonconforming Material/Component
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- Evidence
- device-recall:cfres:108851
- Product
- PrepStain Installation Kit (PreCoat), Catalog/Model # 490528
- Join
- Official recall number ·
Z-1813-2012 - Root cause
- Component design/selection