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-0349-2007 | DRLock Volar Plate Screw System, Model #DVR-900. The product is a kit contained in an... | TORNIER Inc. | HRS | ||
| Z-0481-2011 | T2 Ankle Arthrodesis System Nail and Nut Adapter; Stryker Trauma GmbH... | Howmedica Osteonics Corp | LXH | ||
| Z-1537-06 | Medtronic 3778 Lead Kit, 1x8 Compact Low Impedance Lead Kit for Spinal Cord Stimulation... | Medtronic Neuromodulation | LGW | ||
| Z-1536-06 | Medtronic 3777 Lead Kit, 1x8 Low Impedance Lead Kit for Spinal Cord Stimulation (SCS)... | Medtronic Neuromodulation | LGW | ||
| Z-0045-2007 | Doc-U-Dose Prescription Management System, Item #8-PKIT. The product is distributed in... | Eatonform Inc | NXQ | ||
| Z-1480-06 | Zimmer ZMR Hip System femoral body, revision, nitrided, porous, 12/14 neck taper... | Zimmer GmbH | LPH | ||
| Z-1479-06 | Zimmer ZMR Hip System femoral body, revision, nitrided, porous, 12/14 neck taper... | Zimmer GmbH | LPH | ||
| Z-1478-06 | Zimmer ZMR Hip System femoral body, revision, nitrided, porous, 12/14 neck taper... | Zimmer GmbH | LPH | ||
| Z-1477-06 | Zimmer ZMR Hip System femoral body, revision, nitrided, porous, 12/14 neck taper... | Zimmer GmbH | LPH | ||
| Z-1476-06 | Zimmer ZMR Hip System femoral body, revision, nitrided, porous, 12/14 neck taper... | Zimmer GmbH | LPH | ||
| Z-1475-06 | Zimmer MAYO Conservative hip prosthesis femoral stem, porous, 12/14 neck taper, extra... | Zimmer GmbH | LPH | ||
| Z-1474-06 | Zimmer MAYO Conservative hip prosthesis femoral stem, porous, 12/14 neck taper, large+... | Zimmer GmbH | LPH | ||
| Z-1473-06 | Zimmer Trabecular metal primary hip prosthesis femoral stem, press-fit, collarless, 12/14... | Zimmer GmbH | LPH | ||
| Z-1472-06 | Zimmer Trabecular metal primary hip prosthesis femoral stem, press-fit, collarless, 12/14... | Zimmer GmbH | LPH | ||
| Z-1471-06 | Zimmer Trabecular metal primary hip prosthesis femoral stem, press-fit, collarless, 12/14... | Zimmer GmbH | LPH | ||
| Z-1470-06 | Zimmer VERSYS Hip System Femoral Stem, press-fit, enhanced taper, 12/14 neck taper... | Zimmer GmbH | LWJ | ||
| Z-1469-06 | Zimmer VERSYS Hip System Femoral Stem, press-fit, enhanced taper, 12/14 neck taper... | Zimmer GmbH | LWJ | ||
| Z-1468-06 | Zimmer VERSYS Hip System Femoral Stem, press-fit, enhanced taper, 12/14 neck taper... | Zimmer GmbH | LWJ | ||
| Z-1498-06 | Greiner bio-one * Vacuette Tube * 9C Coagulation Sodium, Citrate 3.2%, * 3.5mL * blue... | Greiner Bio-One North America, Inc. | GIM | ||
| Z-1467-06 | Zimmer VERSYS Hip System Femoral Stem, press-fit, enhanced taper, 12/14 neck taper... | Zimmer GmbH | LWJ | ||
| Z-1429-2010 | Leksell Gamma Knife C | Elekta Limited | IWB | ||
| Z-0193-2007 | BIAD Classic 24 (24 inch collimator). The collimator is a component of the Trionix Biad... | Trionix Research Laboratory, Inc. | KPS | ||
| Z-0050-2007 | Implant Hollow Reamer, 14 mm, REF 8951405, Medtronic Sofamor Danek, Manufactured at... | Medtronic Sofamor Danek Instrument Manufacturing | HTO | ||
| Z-1532-06 | ActiveLife One-Piece Pre-Cut Closed End (ostomy) Pouch with skin barrier and filter 45mm... | ConvaTec Limited | LNO | ||
| Z-1531-06 | ActiveLife One-Piece Pre-Cut Closed End (ostomy) Pouch with skin barrier and filter 45mm... | ConvaTec Limited | LNO | ||
| Z-1518-06 | UniCel Dxl 800 Access Immunoassay Systems Wash Buffer, Part Number 8547197 Wash Buffer | Siemens Healthcare Diagnostics Inc. | JJE | ||
| Z-0035-2007 | SmartSuction Harmony Powered Suction Device Model Number: HAR-E-115-US | Haemonetics Corporation | BTA | ||
| Z-0017-2007 | Hill-Rom VersaCare Hospital Bed with optional patient pendant P3207A01 or P3207A02; model... | Hill-Rom Inc. | FNL | ||
| Z-0197-2007 | Cytomics FC 500 Flow Cytometry System with CXP Software Versions 2.0 & 2.1 | Siemens Healthcare Diagnostics Inc. | GKZ | ||
| Z-0305-2007 | Histochemical PAS (Periodic Acid Schiff) Reaction Set. in vitro diagnostic. Product... | EMD Millipore Corporation | KKS | ||
| Z-1402-06 | Focus * DAILIES * Toric * One-Day Contact Lenses * CIBA Vision | Alcon Laboratories | LPL | ||
| Z-1385-06 | Roche Tina-Quant ASLO (Anti-streptolysin O) Reagent Kit; Catalog No. 1931601 (Roche... | Roche Diagnostics GmbH | GTQ | ||
| Z-1525-06 | BD 1mL SafetyGlide Allergy and Tuberculin Syringes. Reorder Number 305945 and 305950. | Becton Dickinson & Co | MEG | ||
| Z-1487-06 | IntelliVue MultiMeasurement Server (MMS)/Multimeasurement Server, physiological patient... | Philips North America LLC | DQA | ||
| Z-0916-2007 | AcuMatch M-Series Straight Fluted Stem Segment and AcuMatch M-Series Curved Fluted Stem... | Exactech, Inc. | LPH | ||
| Z-1435-06 | MicroScan Lens Disposable Plastic Cap used with MicroScan Video Microscope... | Microvision Medical Holding B.V. | FSO | ||
| Z-1495-06 | CORDIS SV-8 Steerable Guidewire, 300 cm., 5 Steerable Guidewires, Cordis a Johnson... | Cordis US Corp. | DXQ | ||
| Z-1494-06 | CORDIS SV-8 Steerable Guidewire, 180 cm. , 5 Steerable Guidewires, Cordis a Johnson... | Cordis US Corp. | DXQ | ||
| Z-1493-06 | CORDIS-SV-5 Steerable Guidewire, 300 cm.,5 Steerable Guidewires,Cordis a Johnson Johnson... | Cordis US Corp. | DXQ | ||
| Z-1492-06 | CORDIS SV-5 Steerable Guidewire, 180 cm., 5 Steerable Guidewires, Cordis a Johnson... | Cordis US Corp. | DXQ | ||
| Z-1512-06 | Boston Scientific Cutting Balloon Ultra2 Monorail Device, Boston Scientific, One Boston... | Boston Scientific Corporation | LOX | ||
| Z-1415-06 | Medtronic Intrathecal Catheter Distal Revision Kit, Model 8598, (provides replacement... | Medtronic Neuromodulation | LKK | ||
| Z-1414-06 | Medtronic Intrathecal Catheter, Model 8731, (part of infusion systems using Medtronic... | Medtronic Neuromodulation | LKK | ||
| Z-1447-06 | Roche/Hitachi K Electrode, a potassium electrode for use with the Roche/Hitachi models... | Roche Diagnostics GmbH | CEM | ||
| Z-1523-06 | Medline Strider Midi 4 Scooter; a four wheeled battery operated scooter; manufactured by... | MEDLINE INDUSTRIES, LP - Northfield | INI | ||
| Z-1522-06 | Medline Strider Midi 3 Scooter; a three wheeled battery operated scooter; manufactured by... | MEDLINE INDUSTRIES, LP - Northfield | INI | ||
| Z-0037-2007 | Medline Strider Maxi 4 Scooter; a four wheeled battery operated scooter; manufactured by... | MEDLINE INDUSTRIES, LP - Northfield | INI | ||
| Z-0036-2007 | Medline Strider Maxi 3 Scooter; a three wheeled battery operated scooter; manufactured by... | MEDLINE INDUSTRIES, LP - Northfield | INI | ||
| Z-1418-06 | Zimmer Trabecular Metal Reverse Shoulder System Base Plate; Catalog/Ref No... | Zimmer GmbH | KWT | ||
| Z-1417-06 | Zimmer Trabecular Metal Reverse Shoulder System Glenosphere, 40 mm diameter; Catalog/Ref... | Zimmer GmbH | KWT |