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-1938-2016 | Class II | Sterile Sheridan/HVT Cuffed, Murphy Eye, Tracheal Tube, Ref: V5-10314, ID: 7.0 mm, Rx... | Teleflex Medical | BTR | |
| Z-2552-2016 | Class II | ReShape Integrated Dual Balloon System, Gen 1, Catalog No. RSM110, Model No... | Medtimo, Inc. | LTI | |
| Z-1929-2016 | Class II | ExacTrac Vero is a Patient Positioning System for Radiation therapy. | Brainlab, Inc. | IYE | |
| Z-1947-2016 | Class II | Cordis PRECISE (R) RX Nitinol Stent System (Biliary) | Cordis US Corp. | NIM | |
| Z-1946-2016 | Class II | Cordis PRECISE (R) PRO RX Nitinol Stent System (Carotid) | Cordis US Corp. | NIM | |
| Z-1910-2016 | Class II | Stryker FlowPort II Adapter: Model number: 00CAT00778 The FlowPort II Adapter is... | Stryker Corp. | NBH | |
| Z-1684-2016 | Class II | Trilogy self-tapping bone screw Bone screw 4.5x25 selftap 00625004525 Bone screw 4.5x50... | Zimmer Manufacturing B.V. | LPH | |
| Z-1683-2016 | Class II | Hgp ii acetabular cup bone screw selftap 6.5x15mm 00662406515 Hgp ii acetabular cup bone... | Zimmer Manufacturing B.V. | JDI | |
| Z-1682-2016 | Class II | VersaFx Femoral Fixation System Hex head compression screw 4.7 mm dia. 2 inch (51 mm)... | Zimmer Manufacturing B.V. | KTT | |
| Z-1681-2016 | Class II | ITST intertrochanteric/subtrochanteric fixation 4.5 mm diameter cortical screw, 3.5 mm... | Zimmer Manufacturing B.V. | HSB | |
| Z-1680-2016 | Class II | Herbert Cannulated Bone Screw System, Bone Screw, 6.5 mm Dia., 45 mm... | Zimmer Manufacturing B.V. | HWC | |
| Z-1679-2016 | Class II | Mini MagnaFx Cannulated Screw Fixation System Small Cannulated Bone Screw, Fully... | Zimmer Manufacturing B.V. | HWC | |
| Z-1678-2016 | Class II | M/DN Intramedullary Fixation 4.2 mm Diameter Cortical Screw, 3.5 mm Hex Head, 45 mm... | Zimmer Manufacturing B.V. | HSB | |
| Z-1677-2016 | Class II | Zimmer Plates and Screws (ZPS) 4.0 mm Cancellous Screw Fully Threaded, 12 mm Length... | Zimmer Manufacturing B.V. | HWC | |
| Z-1676-2016 | Class II | Periarticular plating system, cancellous bone screw, partially threaded, hex head, 4.0 mm... | Zimmer Manufacturing B.V. | HWC | |
| Z-1675-2016 | Class II | Zimmer universal locking system (ULS) 3.5 mm cortical screw selftapping 18 mm... | Zimmer Manufacturing B.V. | HWC | |
| Z-1674-2016 | Class II | Zimmer Plates and Screws (ZPS) 2.7 mm Cortical Screw SelfTapping, 14 mm Length... | Zimmer Manufacturing B.V. | HWC | |
| Z-1673-2016 | Class II | Zimmer Plates and Screws (ZPS) 3.5 mm Cortical Screw SelfTapping, 10 mm Length... | Zimmer Manufacturing B.V. | HWC | |
| Z-1941-2016 | Class II | Signature TKA GDE/MDL Set 04-05 Patient-specific surgical guide and instrument set. | Materialise USA, LLC. | JWH | |
| Z-1926-2016 | Class II | Medtronic RestoreSensor, Model 37714; and, RestoreSensor SureScan, (MRI), Model 97714... | Medtronic Neuromodulation | LGW | |
| Z-1738-2017 | Class II | DX-D600 - DXD Imaging Package | AGFA Healthcare Corp. | KPR | |
| Z-2039-2016 | Class III | CytoVision Image Analysis and Capture System, an automated cell-locating device. The... | Leica Biosystems Richmond, Inc. | JOY | |
| Z-1949-2016 | Class II | LCP Dia-Meta Volar Distal Radius Plate 15 H Shaft/LT-Sterile; Indicated for fractures... | Synthes (USA) Products LLC | HRS | |
| Z-1912-2016 | Class II | DePuy Synthes 8.0 mm Flexible Shaft Reamer, 360 mm, Orthopedic manual surgical... | Synthes (USA) Products LLC | HTO | |
| Z-1964-2016 | Class II | STAAR AQ Cartridge-FP, guide and delivery system for Intraocular lenses. | Staar Surgical AG | KYB | |
| Z-1920-2016 | Class II | 1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 35 mm - Sterile, Rapid Resorbable... | Synthes (USA) Products LLC | JEY | |
| Z-1919-2016 | Class II | 1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 30 mm - Sterile, Rapid Resorbable... | Synthes (USA) Products LLC | JEY | |
| Z-1918-2016 | Class II | 1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 24 mm - Sterile, Rapid Resorbable... | Synthes (USA) Products LLC | JEY | |
| Z-2041-2016 | Class II | Siemens Healthcare ADVIA Centaur Tnl-Ultra Assay . In-Vitro Diagnostic for quantitative... | Siemens Healthcare Diagnostics Inc. | MMI | |
| Z-2385-2016 | Class II | Ingenuity CT Model No. 728326; To produce cross-sectional images of the body. | Philips North America LLC | JAK | |
| Z-2384-2016 | Class II | Ingenuity Core128 Model No. 728323; To produce cross-sectional images of the body. | Philips North America LLC | JAK | |
| Z-2086-2016 | Class II | Cadence Size 5 Left Tibial Tray Implant, designed to treat ankle arthritis through... | Integra LifeSciences Corporation | HSN | |
| Z-2383-2016 | Class II | Ingenuity Core Model No. 728321; To produce cross-sectional images of the body. | Philips North America LLC | JAK | |
| Z-2382-2016 | Class II | Brilliance iCT SP Model No. 728311; To produce cross-sectional images of the body. | Philips North America LLC | JAK | |
| Z-2381-2016 | Class II | Brilliance iCT, Model No. 728306; To produce cross-sectional images of the body. | Philips North America LLC | JAK | |
| Z-2380-2016 | Class II | Brilliance 64 CT Model 728231; To produce cross-sectional images of the body. | Philips North America LLC | JAK | |
| Z-1939-2016 | Class II | Maestro Air Motor Pneumatic cranial drill motor. The Maestro Air Pneumatic System is a... | Stryker Corp. | HBB | |
| Z-0072-2017 | Class II | ADVIA Centaur XPT Immunoassay System | Siemens Healthcare Diagnostics Inc. | JLW | |
| Z-2098-2016 | Class II | IMPAK ELASTIC ACRYLIC RESIN POWDER & LIQUID, SHADE TRANSPARENT, CONTENTS: 454 gm Powder +... | Cmp Industries, LLC | EBI | |
| Z-2097-2016 | Class II | IMPAK Liquid Acrylic Resin sold under the following labels: 1) IMPAK ELASTIC ACRYLIC... | Cmp Industries, LLC | EBI | |
| Z-1989-2016 | Class II | Excelsior Disposable Syringe Heparin Lock Flush, USP syringe (5 mL Fill in 10 mL... | Excelsior Medical LLC | NZW | |
| Z-1940-2016 | Class II | CENTURION FMS (Fluidics Management System) Pack for the CENTURION Vision System and... | Alcon Laboratories | HQC | |
| Z-1708-2016 | Class II | Reprocessed Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters; Model #... | Stryker Sustainability Solutions | NLH | |
| Z-1881-2016 | Class II | Firebird NXG Spinal Fixation System Set Screw Driver used to insert a set screw into a... | Orthofix SRL | HXX | |
| Z-1703-2016 | Class II | WHIN Infusion Set - 90 Huber Needle and Wing (22 ga/1in). Intravenous delivery through... | B Braun Medical Inc | DQO | |
| Z-1923-2016 | Class II | 4 ml FX Sodium Fluoride/Potassium Oxalate tube, Ref 454297 VACUETTE Glycolytic Inhibitor... | Greiner Bio-One North America, Inc. | JKA | |
| Z-1884-2016 | Class II | Torque Limiting Adapter: Torque Limiting Attachment, Non Sterile, Distributed by... | Greatbatch Medical | HWE | |
| Z-1883-2016 | Class II | Torque Limiting Screwdriver: Greatbatch Medical, Torque Limiting Driver, Non Sterile... | Greatbatch Medical | HXX | |
| Z-1846-2016 | Class II | Reprocessed Microline Scissor Tips intended to be used with a reusable hand piece and... | Sterilmed Inc | NUJ | |
| Z-1882-2016 | Class II | Torque Limiting Handle: PRECIMED, T-Handle Torque, Non Sterile. Handle: Customer... | Greatbatch Medical | HWE |