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-0899-2009 | Omnifit Eon These devices are modular components of a total hip system. These femoral... | Howmedica Osteonics Corp | JDI | ||
| Z-0898-2009 | Omnifit FC Cemented Stem These devices are modular components of a total hip system... | Howmedica Osteonics Corp | JDI | ||
| Z-0897-2009 | Accolade HFx These devices are modular components of a total hip system. These... | Howmedica Osteonics Corp | LZO | ||
| Z-0896-2009 | Omnifit HFX Hip Stem These devices are modular components of a total hip system. These... | Howmedica Osteonics Corp | JDI | ||
| Z-0895-2009 | Accolade C CS These devices are modular components of a total hip system. These... | Howmedica Osteonics Corp | LZO | ||
| Z-0894-2009 | Primary Secur-fit Plus Max Hip Stem These devices are modular components of a total... | Howmedica Osteonics Corp | LZO | ||
| Z-0893-2009 | Secur-Fit Max Hip Stem These devices are modular components of a total hip system... | Howmedica Osteonics Corp | LZO | ||
| Z-0892-2009 | Omnifit Normalized Hip Stem These devices are modular components of a total hip... | Howmedica Osteonics Corp | LZO | ||
| Z-0891-2009 | Omnifit HA Hip Stem These devices are modular components of a total hip system. These... | Howmedica Osteonics Corp | MEH | ||
| Z-0890-2009 | Triathlon-Press-Fit Stem These devices are modular components of a total knee system... | Howmedica Osteonics Corp | JWH | ||
| Z-0889-2009 | Triathlon Cemented Stem - Knee These devices are modular components of a total knee... | Howmedica Osteonics Corp | JWH | ||
| Z-0888-2009 | Solar Shoulder Humeral Stem These devices are modular components of a total shoulder... | Howmedica Osteonics Corp | KWS | ||
| Z-0841-2012 | Axium Detachable Coil System Model Number: QC-2-2-3D. The AXIUM DETACHABLE COIL SYSTEM... | Medtronic, Inc. | HCG | ||
| Z-0926-2009 | Stryker PainPump 2 Blockaid, 400 mL PainPump for Continuous Nerve Block, sterile, 5 per... | Stryker Corp. | FRN | ||
| Z-1068-2009 | Roche/Hitachi Modular Analytics System, clinical chemistry analyzer, Modular P Module... | Roche Diagnostics GmbH | JJE | ||
| Z-1067-2009 | Roche/Hitachi Modular Analytics System, clinical chemistry analyzer, Modular D Module... | Roche Diagnostics GmbH | JJE | ||
| Z-1066-2009 | Roche/Hitachi Modular Analytics System, clinical chemistry analyzer, Modular P800 Module... | Roche Diagnostics GmbH | JJE | ||
| Z-1065-2009 | Roche/Hitachi Modular Analytics System, clinical chemistry analyzer Modular D2400... | Roche Diagnostics GmbH | JJE | ||
| Z-1963-2009 | BD Diagnostics, BD GeneOhm MRSA Assay, REF: 441242 (200 Reaction Kit) and 441244 (48... | BD Diagnostics (Geneohm Sciences, Inc.) | NQX | ||
| Z-0506-2009 | Hill-Rom 70 Semi-Electric Bed, Hill-Rom Company, Batesville, IN.; Model HS-968. The bed... | Hill-Rom Inc. | FNL | ||
| Z-0606-2009 | Liko AB Uno Lifts, Powered (non-AC) Patient Lift: Old Uno 102: S/N 20001 through... | Liko, Inc. | FSA | ||
| Z-0605-2009 | Liko AB Uno Lifts, Powered (non-AC) Patient Lift: Uno 100 EM/EE: S/N 7090001 through... | Liko, Inc. | FSA | ||
| Z-0643-2009 | ACIST CVi Angiographic Injection System with Interface Cable for Toshiba Infinix-i... | Acist Medical Systems, Inc. | DXT | ||
| Z-0980-2009 | Cook Medical Universa Soft Ureteral Stent and Positioner with Hydrophilic Coating... | Cook Incorporated | FAD | ||
| Z-1230-2010 | Leksell Gamma Knife Perfexion, Radionuclide radiation therapy system. Article Number... | Elekta Limited | IWB | ||
| Z-1509-2009 | ReSolve Halo - Open Back Halo Ring, Model Number: 510400D The ReSolve Halo Ring is a... | Ossur Engineering, Inc | HAX | ||
| Z-1508-2009 | ReSolve Halo - Open Back Halo Ring, Model Number: 505400D The ReSolve Halo Ring is a... | Ossur Engineering, Inc | HAX | ||
| Z-1507-2009 | ReSolve Halo - Open Back Halo Ring, Model Number: 505300D The ReSolve Halo Ring is a... | Ossur Engineering, Inc | HAX | ||
| Z-0968-2010 | OvuChek Saliva Ovulation Disposable Test Strips; 5 disposable test strips per pouch... | Quest Products, Inc | NGE | ||
| Z-0968-2009 | NFlex Stabilization System 150 mm, Catalog number NF60150-1. spinal fusion surgery | Synthes GmbH | NPQ | ||
| Z-0967-2009 | NFlex Stabilization System 200 mm, Catalog number NF60020-1. spinal fusion surgery | Synthes GmbH | NPQ | ||
| Z-0966-2009 | TI N-Hance Rod 150 mm Sterile, Catalog number 04.600.715.02S spinal fusion surgery | Synthes GmbH | NQP | ||
| Z-0965-2009 | N-Hance System 150 mm, Catalog number NH60150-1. spinal fusion surgery | Synthes GmbH | NQP | ||
| Z-0964-2009 | NFix II System 200 mm, Catalog number NX60200-1. spinal fusion surgery | Synthes GmbH | NQP | ||
| Z-0963-2009 | NFix II System 150 mm, Catalog number NX60150-1 spinal fusion surgery | Synthes GmbH | NQP | ||
| Z-0910-2009 | Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power... | Terumo Cardiovascular Systems Corporation | DTQ | ||
| Z-0909-2009 | Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A... | Terumo Cardiovascular Systems Corporation | DTQ | ||
| Z-0614-2009 | ReSolve Hydrophilic Coated Locking Biliary Catheter, REF RBC-14-038, 14F, Sterile EO... | Merit Medical Systems, Inc. | FGE | ||
| Z-0613-2009 | ReSolve Hydrophilic Coated Locking Biliary Catheter, 12F, REF RBC-12-038, Sterile EO... | Merit Medical Systems, Inc. | FGE | ||
| Z-0612-2009 | ReSolve Hydophilic Coated Locking Biliary Catheter, REF RBC-10-038, 10F, Sterile EO... | Merit Medical Systems, Inc. | FGE | ||
| Z-0611-2009 | ReSolve Hydrophilic Coated Locking Biliary Catheter, REF RBC-8-038, 8.5 F, Sterile EO... | Merit Medical Systems, Inc. | FGE | ||
| Z-0925-2009 | Stryker PainPump Two Site Infusion Set, sterile, 10 per box. Manufactured for Stryker... | Stryker Corp. | FRN | ||
| Z-0924-2009 | Stryker PainPump Two Site Infusion Kit with ExFen 5.0", 120 mL Infusion Kit, sterile, 5... | Stryker Corp. | FRN | ||
| Z-0923-2009 | Stryker PainPump, Two Site Infusion Kit with ExFen 2.5", 120 mL Infusion Kit, sterile, 5... | Stryker Corp. | FRN | ||
| Z-1031-2009 | Zimmer Silhouette Axial Torque Handle, Zimmer Spine, Inc., Minneapolis, MN; REF... | Zimmer GmbH | HXC | ||
| Z-1088-2009 | Triage Drugs of Abuse Panel, Model Number: 95000. Is an immunoassay test kit used for... | Alere San Diego, Inc. | DKZ | ||
| Z-0646-2009 | Drive Belt for Radiation Therapy Simulation systems SIMVIEW 3000 and SIMVIEW NT with CT... | Siemens Medical Solutions USA, Inc. | KPQ | ||
| Z-0651-2009 | High-low:x frame for the x:panda mechanical chair. | R82 Inc. | IMS | ||
| Z-1040-2009 | QCA and iQCA software, a video microscopy software system for quantitative estrogen... | Leica Microsystems, Inc. | NQN | ||
| Z-0939-2009 | VOYAGER NC Coronary Dilatation Catheter, 4.5 X 12.0 mm. The device is used for in the... | Abbott Vascular | LOX |