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-2439-2011 | Ringloc + Acetabular Shell limited hole, 58 mm Size 25, porous coat, for uncemented use... | Zimmer GmbH | KWA | ||
| Z-2438-2011 | Ringloc + Acetabular Shell limited hole, 56 mm Size 24, porous coat, for uncemented use... | Zimmer GmbH | KWA | ||
| Z-2437-2011 | Ringloc + Acetabular Shell limited hole, 54 mm Size 24, porous coat, for uncemented use... | Zimmer GmbH | KWA | ||
| Z-2436-2011 | Ringloc + Acetabular Shell limited hole, 52 mm Size 23, porous coat, for uncemented use... | Zimmer GmbH | KWA | ||
| Z-2435-2011 | Ringloc + Acetabular Shell limited hole, 50 mm Size 23, porous coat, for uncemented use... | Zimmer GmbH | KWA | ||
| Z-2434-2011 | Ringloc + Acetabular Shell limited hole, 48 mm Size 22, porous coat, for uncemented use... | Zimmer GmbH | KWA | ||
| Z-2433-2011 | Ringloc + Acetabular Shell limited hole, 46 mm Size 22 porous coat, for uncemented use... | Zimmer GmbH | KWA | ||
| Z-2432-2011 | Ringloc + Acetabular Shell limited hole finned 70 mm Size 28 porous coat, for uncemented... | Zimmer GmbH | KWA | ||
| Z-2431-2011 | Ringloc + Acetabular Shell limited hole finned 66 mm Size 27 porous coat, for uncemented... | Zimmer GmbH | KWA | ||
| Z-2430-2011 | Ringloc + Acetabular Shell limited hole finned 64 mm Size 26 porous coat, for uncemented... | Zimmer GmbH | KWA | ||
| Z-2429-2011 | Ringloc + Acetabular Shell limited hole finned 62 mm Size 26 porous coat, for uncemented... | Zimmer GmbH | KWA | ||
| Z-2428-2011 | Ringloc + Acetabular Shell limited hole finned 60 mm Size 25 porous coat, for uncemented... | Zimmer GmbH | KWA | ||
| Z-2427-2011 | Ringloc + Acetabular Shell limited hole finned 58 mm Size 25 porous coat, for uncemented... | Zimmer GmbH | KWA | ||
| Z-2426-2011 | Ringloc + Acetabular Shell limited hole finned 56 mm Size 24 porous coat, for uncemented... | Zimmer GmbH | KWA | ||
| Z-2425-2011 | Ringloc + Acetabular Shell limited hole finned 54 mm Size 24 porous coat, for uncemented... | Zimmer GmbH | KWA | ||
| Z-2424-2011 | Ringloc + Acetabular Shell limited hole finned 52 mm Size 23 porous coat, for uncemented... | Zimmer GmbH | KWA | ||
| Z-2423-2011 | Ringloc + Acetabular Shell limited hole finned 50 mm Size 23 porous coat, for uncemented... | Zimmer GmbH | KWA | ||
| Z-2422-2011 | Ringloc + Acetabular Shell limited hole finned 48 mm Size 22 porous coat, for uncemented... | Zimmer GmbH | KWA | ||
| Z-2421-2011 | Ringloc + Acetabular Shell limited hole finned 46 mm Size 22 porous coat, for uncemented... | Zimmer GmbH | KWA | ||
| Z-2222-2011 | Baxter Colleague, Colleague CX and Colleague CXE Infusion Pumps, Single Channel... | Baxter Healthcare Corporation | FRN | ||
| Z-2227-2011 | Unicel DxH 800 Coulter Cellular Analysis System. A quantitative, automated hematology... | Siemens Healthcare Diagnostics Inc. | GKZ | ||
| Z-2580-2011 | MTD 4000 - Mettler Traction Decompression System, Model: ME 4000 Product Usage: Provide... | Mettler Electronics Corp | ITH | ||
| Z-2587-2011 | COBAS AmpliPrep / COBAS TaqMan HCV Test, CE-IVD The COBAS AmpliPrep/COBAS TaqMan HCV... | Roche Molecular Systems Inc | MZP | ||
| Z-2586-2011 | COBAS AmpliPrep / COBAS TaqMan HCV Test, US-IVD The COBAS AmpliPrep/COBAS TaqMan HCV... | Roche Molecular Systems Inc | MZP | ||
| Z-2466-2011 | Regenerex (TM) Ringloc +, Limited Hole Acetablular Cup, 60 mm Size 25, with Locking... | Zimmer GmbH | LPH | ||
| Z-2465-2011 | Regenerex (TM) Ringloc +, Limited Hole Acetablular Cup, 56 mm Size 24, with Locking... | Zimmer GmbH | LPH | ||
| Z-2464-2011 | Regenerex (TM) Ringloc +, Limited Hole Acetablular Cup, 54 mm Size 23, with Locking... | Zimmer GmbH | LPH | ||
| Z-2463-2011 | Regenerex (TM) Ringloc +, Limited Hole Acetablular Cup, 52 mm Size 23, with Locking... | Zimmer GmbH | LPH | ||
| Z-2462-2011 | Regenerex (TM) Ringloc +, Limited Hole Acetablular Cup, 50 mm Size 22, with Locking Ring... | Zimmer GmbH | LPH | ||
| Z-2461-2011 | Regenerex (TM) Ringloc +, Limited Hole Acetablular Cup, 48 mm Size 22, with Locking... | Zimmer GmbH | LPH | ||
| Z-2460-2011 | Regenerex (TM) Ringloc +, Multi Hole Acetablular Cup, 74 mm Size 28, with Lock Ring... | Zimmer GmbH | LPH | ||
| Z-2459-2011 | Regenerex (TM) Ringloc +, Multi Hole Acetablular Cup, 70 mm Size 27, with Lock Ring... | Zimmer GmbH | LPH | ||
| Z-2458-2011 | Regenerex (TM) Ringloc +, Multi Hole Acetablular Cup, 66 mm Size 26, with Lock Ring... | Zimmer GmbH | LPH | ||
| Z-2692-2011 | Software versions Eos software versions: 1.2.4, 1.2.5, 1.2.6,1.2.7,1.2.8, 1.2.9,1.2.10... | EOS imaging | LLZ | ||
| Z-2244-2011 | BacT/ALERT - FA Reagent Bottle The BacT/ALERT Microbial Detection System is used to... | bioMerieux, Inc. | MDB | ||
| Z-0344-2013 | Class II | IO Fix IntraOsseous Fixation System; Extremity Medical. www.extremitymedical.com... | Extremity Medical, LLC | HWC | |
| Z-1073-2012 | VITROS 5600 Integrated Systems, Catalog # 6802413; COMMON/USUAL NAME: VITROS 5600... | Ortho-Clinical Diagnostics, Inc. | JJE | ||
| Z-1072-2012 | VITROS 3600 Immunodiagnostics Systems, Catalog # 6802783; COMMON/USUAL NAME: VITROS... | Ortho-Clinical Diagnostics, Inc. | JJE | ||
| Z-2671-2011 | B. Braun Celsite Venous Access Ports , Distributed by Aesculpa Inc. Model ST301, ST305V... | B. BRAUN INTERVENTIONAL SYSTEMS Inc. | LJT | ||
| Z-2597-2011 | Peloris II Rapid Tissue Processor; Leica Biosystems Melbourne Pty Ltd, Mount Waverly... | Leica Microsystems, Inc. | IEO | ||
| Z-2124-2011 | BardVentralex" Hernia Patch Medium Circle with Strap Diameter 6.4cm /2.5",\ Catalog... | Davol Inc., Sub. C.R. Bard, Inc. | FTL | ||
| Z-3063-2011 | Sysmex Stromatolyser-IM; a lytic reagent for use with the XE-2100, XE-2100L and XE-5000... | Sysmex America, Inc. | GGK | ||
| Z-2634-2011 | ***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, FL, USA 32615***Distributed... | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | MQV | ||
| Z-2231-2011 | COULTER Ac"T" 5diff Fix Reagent. Part Number: 8547171 COULTER AC"T" 5diff Fix... | Siemens Healthcare Diagnostics Inc. | GGK | ||
| Z-3206-2011 | DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500 (GE Healthcare) | GE Healthcare | DPZ | ||
| Z-2571-2011 | Ca++ Membrane Units, Model #942-046, and Model #942-060 used on ABL505/555, EML105... | Radiometer America, Inc | JFP | ||
| Z-2713-2011 | Comprehensive Shoulder Instruments Fracture Stem Inserter w/Version Control, REF... | Zimmer GmbH | LXH | ||
| Z-2712-2011 | Comprehensive Shoulder Instruments Primary Shoulder Stem Inserter, REF 407398, Biomet... | Zimmer GmbH | LXH | ||
| Z-2400-2011 | ES0102-45, AEM Disposable Curved Scissors, 3/4", 45cm, Sterile R, Encision Inc., Boulder... | Encision, Inc. | GEI | ||
| Z-2399-2011 | ES0101-45, AEM Disposable Curved Scissors, 1/2", 45cm, Sterile R, Encision Inc., Boulder... | Encision, Inc. | GEI |