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-1671-2010 | Mallory Head Calcar Femoral, 34 mm resection/porous coated, 9.0 mm x 220 mm right stem... | Zimmer GmbH | LPH | ||
| Z-1670-2010 | Mallory Head Calcar Provisional, 55 mm resection/porous coated, 17.0 mm x 260 mm left... | Zimmer GmbH | LPH | ||
| Z-1669-2010 | Mallory Head Calcar Femoral, 34 mm resection/porous coated, 15.0 mm x 170 mm stem... | Zimmer GmbH | LPH | ||
| Z-1668-2010 | Mallory Head Calcar Femoral, 34 mm resection/porous coated, 13.0 x 170 mm,, Sterile... | Zimmer GmbH | LPH | ||
| Z-1667-2010 | Mallory Head Calcar Femoral, 34 mm resection/porous coated, 9mm x 170 mm stem, Sterile... | Zimmer GmbH | LPH | ||
| Z-1666-2010 | Mallory Head Calcar Provisional, 45 mm replacement stem, 13.0 x 220 mm left, Sterile... | Zimmer GmbH | LPH | ||
| Z-1665-2010 | Mallory Head Calcar Provisional, 34 mm replacement stem, 11 mm x 220 mm left, Sterile... | Zimmer GmbH | LPH | ||
| Z-2239-2010 | The Starion Instruments Thermal Ligating Shears 35C Model 102-138D and 23C Model numbers... | Microline Surgical, Inc | GEI | ||
| Z-1537-2010 | Medtronic HMS PLUS, Hemostasis Management System. Medtronic, Inc., Cardiovascular... | Medtronic, Inc. | JPA | ||
| Z-1256-2010 | NicoletOne vEEG System, VIASYS Healthcare, Inc., Madison, Wisconsin 53711. | CareFusion 303, Inc | GWQ | ||
| Z-1252-2010 | CareSuite" - Critical Care Manager, PACU Manager and Anesthesia Manager Software... | Picis Clinical Solutions, Inc. | NSX | ||
| Z-2424-2010 | NeoMarkers Rabbit Monoclonal anti-Human Cyclin D1 Antibody (Clone SP4), immunochemistry... | Lab Vision Corp. | NJT | ||
| Z-2174-2010 | BD GeneOhm Cdiff Assay, Catalog 441401, 200 tests/kit, labeled, in part ***BD... | Becton Dickinson & Co | LLH | ||
| Z-2059-2010 | DePuy ASR 300 Acetabular Implant, 70 mm, 999830770, sterile, DePuy International, Ltd... | Depuy Orthopaedics Inc. | KWA | ||
| Z-2058-2010 | DePuy ASR 300 Acetabular Implant, 68 mm, 999830768, sterile, DePuy International, Ltd... | Depuy Orthopaedics Inc. | KWA | ||
| Z-2057-2010 | DePuy ASR 300 Acetabular Implant, 66 mm, 999830766, sterile, DePuy International, Ltd... | Depuy Orthopaedics Inc. | KWA | ||
| Z-2056-2010 | DePuy ASR 300 Acetabular Implant, 64 mm, 999830764, sterile, DePuy International, Ltd... | Depuy Orthopaedics Inc. | KWA | ||
| Z-2055-2010 | DePuy ASR 300 Acetabular Implant, 62 mm, 999830762, sterile, DePuy International, Ltd... | Depuy Orthopaedics Inc. | KWA | ||
| Z-2054-2010 | DePuy ASR 300 Acetabular Implant, 60 mm, 999830760, sterile, DePuy International, Ltd... | Depuy Orthopaedics Inc. | KWA | ||
| Z-2053-2010 | DePuy ASR 300 Acetabular Implant, 58 mm, 999830758, sterile, DePuy International, Ltd... | Depuy Orthopaedics Inc. | KWA | ||
| Z-2052-2010 | DePuy ASR 300 Acetabular Implant, 56 mm, 999830756, sterile, DePuy International, Ltd... | Depuy Orthopaedics Inc. | KWA | ||
| Z-2051-2010 | DePuy ASR 300 Acetabular Implant, 54 mm, 999830754, sterile, DePuy International, Ltd... | Depuy Orthopaedics Inc. | KWA | ||
| Z-2050-2010 | DePuy ASR 300 Acetabular Implant, 52 mm, 999830752, sterile, DePuy International, Ltd... | Depuy Orthopaedics Inc. | KWA | ||
| Z-2049-2010 | DePuy ASR 300 Acetabular Implant, 50 mm, 999830750, sterile, DePuy International, Ltd... | Depuy Orthopaedics Inc. | KWA | ||
| Z-2048-2010 | DePuy ASR 300 Acetabular Implant, 48 mm, 999830748, sterile, DePuy International, Ltd... | Depuy Orthopaedics Inc. | KWA | ||
| Z-2047-2010 | DePuy ASR 300 Acetabular Implant, 46 mm, 999830746, sterile, DePuy International, Ltd... | Depuy Orthopaedics Inc. | KWA | ||
| Z-2046-2010 | DePuy ASR 300 Acetabular Implant, 44 mm, 999830744, sterile, DePuy International, Ltd... | Depuy Orthopaedics Inc. | KWA | ||
| Z-2045-2010 | DePuy ASR 100 Acetabular Implant, 70 mm, 999806370, sterile, DePuy International, Ltd... | Depuy Orthopaedics Inc. | KWA | ||
| Z-2044-2010 | DePuy ASR 100 Acetabular Implant, 68 mm, 999806168, sterile, DePuy International, Ltd... | Depuy Orthopaedics Inc. | KWA | ||
| Z-2043-2010 | DePuy ASR 100 Acetabular Implant, 64 mm, 999805764, sterile, DePuy International, Ltd... | Depuy Orthopaedics Inc. | KWA | ||
| Z-2042-2010 | DePuy ASR 100 Acetabular Implant, 62 mm, 999800762, sterile, DePuy International, Ltd... | Depuy Orthopaedics Inc. | KWA | ||
| Z-2041-2010 | DePuy ASR 100 Acetabular Implant, 60 mm, 999800760, sterile, DePuy International, Ltd... | Depuy Orthopaedics Inc. | KWA | ||
| Z-2040-2010 | DePuy ASR 100 Acetabular Implant, 66 mm, 999805966, sterile, DePuy International, Ltd... | Depuy Orthopaedics Inc. | KWA | ||
| Z-2039-2010 | DePuy ASR 100 Acetabular Implant, 58 mm, 999800758, sterile, DePuy International, Ltd... | Depuy Orthopaedics Inc. | KWA | ||
| Z-2038-2010 | DePuy ASR 100 Acetabular Implant, 57 mm, 999890157, sterile, DePuy International, Ltd... | Depuy Orthopaedics Inc. | KWA | ||
| Z-2037-2010 | DePuy ASR 100 Acetabular Implant, 56 mm, 999800756, sterile, DePuy International, Ltd... | Depuy Orthopaedics Inc. | KWA | ||
| Z-2036-2010 | DePuy ASR 100 Acetabular Implant, 54 mm, 999800754, sterile, DePuy International, Ltd... | Depuy Orthopaedics Inc. | KWA | ||
| Z-2035-2010 | DePuy ASR 100 Acetabular Implant, 52 mm, 999800752, sterile, DePuy International, Ltd... | Depuy Orthopaedics Inc. | KWA | ||
| Z-203-2010 | DePuy ASR 100 Acetabular Implant, 50 mm, 999800750, sterile, DePuy International, Ltd... | Depuy Orthopaedics Inc. | KWA | ||
| Z-2033-2010 | DePuy ASR 100 Acetabular Implant, 48 mm, 999800748, sterile, DePuy International, Ltd... | Depuy Orthopaedics Inc. | KWA | ||
| Z-2032-2010 | DePuy ASR 100 Acetabular Implant, 46 mm, 999800746, sterile, DePuy International, Ltd... | Depuy Orthopaedics Inc. | KWA | ||
| Z-2031-2010 | DePuy ASR 100 Acetabular Implant, 44 mm, 999800744, sterile, DePuy International, Ltd... | Depuy Orthopaedics Inc. | KWA | ||
| Z-0333-2011 | Excel Care ES Bariatric Bed, P 610B, Hill-Rom, Batesville, IN. Intended use: The... | Hill-Rom Inc. | FNL | ||
| Z-0332-2011 | Excel Care Bariatric Bed, P 610A, Hill-Rom, Batesville, IN. Intended Use: The Excel... | Hill-Rom Inc. | FNL | ||
| Z-1550-2010 | Inion 1.5 x 6mm CPS(R) Baby Screw, 1.5mm Inion CPS(R) Baby 5+E, REF SCR 1221, 5/pack... | Stryker Craniomaxillofacial Division | HWC | ||
| Z-1561-2010 | PM1000 Flow Selector - An accessory to an emergency ventilator (resuscitator). The... | Precision Medical, Inc. | BTM | ||
| Z-1216-2010 | AccuMax Quantum Complete (Model CU3/CU4), an alternating pressure with turn assist & on... | Encompass Therapeutic Support Systems dba BG North America | FNM | ||
| Z-1650-2010 | Bard Mesh Monofilament Knitted Polypropylene Flat Mesh; size 6" x 6", 3 per box; Davol... | Ram Medical Inc | FTL | ||
| Z-1649-2010 | Bard Mesh Monofilament Knitted Polypropylene; size 3" x 6", 3 units per box. Davol Inc. A... | Ram Medical Inc | FTL | ||
| Z-1648-2010 | Bard Mesh Monofilament Knitted Polypropylene; size 10 x 14", 3 units per box; Davol Inc... | Ram Medical Inc | FTL |