Device recalls
Recall records from FDA, newest initiation date first.
Every device recall MDM has ingested. The recall record supplies the product, the reason and the product code; the matching enforcement report supplies the Class I, II or III classification. Where the two have not been joined, the class is left blank rather than assumed.
Data as of , the FDA export date. FDA medical device recall database
| Recall number | Class | Product | Recalling firm | Product code | Initiated |
|---|---|---|---|---|---|
| Z-2062-2008 | Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 5 x... | Allez Spine, LLC | MNI | ||
| Z-2061-2008 | Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 5 x... | Allez Spine, LLC | MNI | ||
| Z-2060-2008 | Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 5 x... | Allez Spine, LLC | MNI | ||
| Z-0592-2008 | Hoana LifeBed Patient Vigilance System, (Intelligent Medical Vigilance System),Model... | Hoana Medical, Inc. | KMI | ||
| Z-2214-2008 | Biomet OSS (Orthopedic Salvage System) RS Non-Modular Long Tibial Base, 75mm x 10 x... | Zimmer GmbH | JDI | ||
| Z-2213-2008 | OSS (Orthopedic Salvage System) RS Non-Modular Long Tibial Base, Porous Coated, 71mm x 10... | Zimmer GmbH | KRO | ||
| Z-0099-2009 | PRIMEVIEW 3i System 2.1 equipped with a Coherence Therapist R2.0 or R2.1, and PRIMEVIEW... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-0098-2009 | Coherence Therapist System 2.1 equipped with a Coherence Therapist R2.0 or R2.1, and... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-0097-2009 | PRIMEVIEW 3i System 2.0 equipped with a Coherence Therapist R2.0 or R2.1, and PRIMEVIEW... | Siemens Medical Solutions USA, Inc. | |||
| Z-0096-2009 | Coherence Therapist 2.0 equipped with a Coherence Therapist R2.0 or R2.1, and PRIMEVIEW... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-0095-2009 | Syngo Based WS for 3rd party equipped with a Coherence Therapist R2.0 or R2.1, and... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-0094-2009 | Impression Therapist 3rd party V&R equipped with a Coherence Therapist R2.0 or R2.1, and... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-0093-2009 | AG Therapist 3rd party V&R equipped with a Coherence Therapist R2.0 or R2.1, and... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-0092-2009 | PRIMEVIEW 3i System equipped with a Coherence Therapist R2.0 or R2.1, and PRIMEVIEW... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-0091-2009 | Coherence Impression Therapist System equipped with a Coherence Therapist R2.0 or R2.1... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-0090-2009 | Coherence Therapist System Part number 7339125 Medical charged-particle radiation... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-0089-2009 | Coherence AG Therapist Part number 5863506, equipped with a Coherence Therapist R2.0 or... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-0565-2008 | Ethicon Endopath 5 mm Curved Dissector with Monopolar Cautery, Product Code: 5DCD... | Ethicon Endo-Surgery Inc | GDI | ||
| Z-0518-2008 | Magnetom Espree with Swiveling OR (Operating Room) Table, Magnetic Resonance Imaging... | Siemens Medical Solutions USA, Inc. | LNH | ||
| Z-0457-2008 | bioMerieux, BacT/ALERT FA Culture Bottles, bioMerieux, Inc., Durham, NC 27704 | bioMerieux, Inc. | MDB | ||
| Z-2655-2010 | SLT transducer is used on the SonoSite MicroMaxx ultrasound system. The SLT Transducer... | FUJIFILM SonoSite,Inc. | IYN | ||
| Z-2654-2010 | Laparoscopic Ultrasound Transducer (LAP Transducer) is used on the SonoSite MicroMaxx... | FUJIFILM SonoSite,Inc. | IYN | ||
| Z-2240-2008 | NobelReplace Tapered Groovy RP 4.3x10mm. These products are root-form endosseous... | Nobel Biocare USA LLC | DZE | ||
| Z-0970-2008 | Stryker Trial Head xx-Long (+16mm) Neck Length 32mm Diameter Sterile, Forged Vitallium... | Howmedica Osteonics Corp | JDI | ||
| Z-0969-2008 | Stryker Trial Head xx-Long (+16mm) Neck Length 28mm Diameter Sterile, Forged Vitallium... | Howmedica Osteonics Corp | JDI | ||
| Z-0968-2008 | Stryker Trial Head xx-Long (+16mm) Neck Length 26mm Diameter Sterile, Forged Vitallium... | Howmedica Osteonics Corp | JDI | ||
| Z-0967-2008 | Stryker LFIT COCR V40 Femoral Head; xx-Long (+16mm) Neck Length 32mm Diameter Sterile... | Howmedica Osteonics Corp | JDI | ||
| Z-0966-2008 | Stryker LFIT COCR V40 Femoral Head; xx-Long (+16mm) Neck Length 28mm Diameter Sterile... | Howmedica Osteonics Corp | JDI | ||
| Z-0965-2008 | Stryker LFIT COCR V40 Femoral Head; xx-Long (+16mm) Neck Length 26mm Diameter Sterile... | Howmedica Osteonics Corp | JDI | ||
| Z-0964-2008 | Stryker COCR V40 Femoral Head; xx-Long (+16mm) Neck Length 32mm Diameter Sterile, Forged... | Howmedica Osteonics Corp | JDI | ||
| Z-0963-2008 | Stryker COCR V40 Femoral Head; xx-Long (+16mm) Neck Length 28mm Diameter Sterile, Forged... | Howmedica Osteonics Corp | JDI | ||
| Z-0962-2008 | Stryker COCR V40 Femoral Head; xx-Long (+16mm) Neck Length, 26mm Diameter ; Sterile... | Howmedica Osteonics Corp | JDI | ||
| Z-0452-2008 | Conmed Accessory Electrode, Universal Electrodes, Part/REF Numbers : 138100 through... | ConMed Corporation | GEI | ||
| Z-0726-2008 | Nova - EZ CHEM Linearity Solution P/N 9618, Nova Biomedical, Waltham, MA 02454 | Nova Biomedical Corporation | CGL | ||
| Z-0725-2008 | Nova - EZ CHEM Control Solution P/N 9612, Nova Biomedical, Waltham, MA 02454 | Nova Biomedical Corporation | CGL | ||
| Z-0724-2008 | Nova - EZ CHEM Creatinine Meter: SRS Versions 5.1 and 5.2 P/N 9600, Nova Biomedical... | Nova Biomedical Corporation | CGL | ||
| Z-0357-2008 | Stryker inTouch Zoom Critical Care bed, Model 2140, Stryker Medical, Portage, MI 49002 | Stryker Medical | FNL | ||
| Z-0356-2008 | Stryker inTouch Critical Care bed; Model 2130, Stryker Medical, Portage, MI 49002 | Stryker Medical | FNL | ||
| Z-0842-2008 | GE Healthcare Proteus XR/a Radiographic X-ray System, Model Number 2259976; previously... | GE Healthcare | KPR | ||
| Z-0709-2008 | Caspar Titanium Aneurysm Clip Appliers, Catalog No/Part #: FT430T, Casper Applier F/Std... | Aesculap Inc | HCI | ||
| Z-0708-2008 | Caspar Titanium Aneurysm Clip Appliers, Catalog No/Part #: FT420T, Casper Applier F/Mini... | Aesculap Inc | HCI | ||
| Z-0572-2008 | Exactech 12/14 Biolox Alumina Femoral Head 28MM +3.5, hip prosthesis component, Exactech... | Exactech, Inc. | LPH | ||
| Z-0552-2008 | AADCO Rayshield Frame Mounted Overhead X-Ray Barrier; Models: E3051AR S-568, 60 x 80 cm... | Aadco Medical Inc. | IWX | ||
| Z-2458-2008 | ConMed Linvatec Surgical Video Cart, Catalogue Number: VP8500 | Conmed Linvatec Endoscopy Division | KQM | ||
| Z-0916-2008 | Grengloo (Unidose Tips), Bracket adhesive and tooth conditioner, Part Number 740-0322... | Ormco/Sybronendo | DYH | ||
| Z-0737-2008 | Sechrist Hyperbaric Chamber Gurney, Standard Gurney Without Siderails & Stretcher Model... | Sechrist Industries Inc | FPO | ||
| Z-0736-2008 | Sechrist Hyperbaric Chamber Gurney, Hydraulic Gurney & Standard Stretcher Model, P/N... | Sechrist Industries Inc | FPO | ||
| Z-0735-2008 | Sechrist Hyperbaric Chamber Gurney, Hydraulic Gurney & Deluxe Wide Stretcher Model, P/N... | Sechrist Industries Inc | FPO | ||
| Z-0734-2008 | Sechrist Hyperbaric Chamber Gurney, Standard Gurney & Deluxe Wide Stretcher Model, P/N... | Sechrist Industries Inc | FPO | ||
| Z-0733-2008 | Sechrist Hyperbaric Chamber Gurney, Standard Gurney & Stretcher Model, P/N : 21502... | Sechrist Industries Inc | FPO |