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-2091-2008 | Boston Scientific LeVeen SuperSlim Needle Electrode, 2.0 cm/15 cm, sterile. The device... | Boston Scientific Corporation | GEI | ||
| Z-1118-2008 | Fisher Healthcare Sure-Vue Serum/Urine hCG-STAT; in vitro diagnostic test; Catalog... | Innovacon, Inc. | JHI | ||
| Z-0694-2008 | Medtronic Soletra 7426, Quadripolar Multi-Programmable Neurostimulator for Deep Brain... | Medtronic Neuromodulation | MHY | ||
| Z-0693-2008 | Medtronic Kinetra 7428, Dual Program Neurostimulator for Deep Brain Stimulation, Rx... | Medtronic Neuromodulation | MHY | ||
| Z-0293-2008 | Toshiba-Interventional Angiography System, Infinix i, Model DFP-8000D, equiped with... | Canon Medical Systems USA, Inc. | MQB | ||
| Z-0477-2008 | Medtronic Blood Collection Reservoir, 40 micron,Catalog/Model # EL240, Medtronic, Inc... | Medtronic Perfusion Systems | DTN | ||
| Z-0476-2008 | Medtronic Trillium Affinity NT, 541T, Integrated CVR/Membrane Oxygenator (Plasma... | Medtronic Perfusion Systems | DTZ | ||
| Z-0127-2008 | Abbott AxSYM AUSAB Reagent Pack, List No: 3C74-20, 100 tests, an in-vitro test for... | Abbott Medical | LOM | ||
| Z-0717-2008 | GE Healthcare, Mobile Fluoroscopy X-Ray System, OEC, Model 7700, GE Healthcare, Surgery... | GE Healthcare | JAA | ||
| Z-0716-2008 | GE Healthcare, Mobile Fluoroscopy X-Ray System, OEC Model 7600, GE Healthcare, Surgery... | GE Healthcare | JAA | ||
| Z-0474-2008 | Hipstar V40 Femoral Stem-127 degrees; N degrees 3 high offset 31 mm;Sterile; Catalog No... | Howmedica Osteonics Corp | LPH | ||
| Z-0473-2008 | Hipstar V40 Femoral Stem-127 degrees; N degrees 3 high offset 31 mm;Sterile; Catalog No... | Howmedica Osteonics Corp | LPH | ||
| Z-0472-2008 | Hipstar V40 Femoral Stem-127 degrees; N degrees 3 high offset 31 mm;Sterile; Catalog No... | Howmedica Osteonics Corp | LPH | ||
| Z-0471-2008 | Hipstar V40 Femoral Stem-127 degrees; N degrees 3 high offset 31 mm;Sterile; Catalog No... | Howmedica Osteonics Corp | LPH | ||
| Z-0470-2008 | Hipstar V40 Femoral Stem-127 degrees; N degrees 3 high offset 31 mm;Sterile; Catalog No... | Howmedica Osteonics Corp | LPH | ||
| Z-0469-2008 | Hipstar V40 Femoral Stem-127 degrees; N degrees 3 high offset 31 mm;Sterile; Catalog No... | Howmedica Osteonics Corp | LPH | ||
| Z-0468-2008 | Hipstar V40 Femoral Stem 127 degrees; N degrees 3 high offset 31 mm;Sterile; Catalog No... | Howmedica Osteonics Corp | LPH | ||
| Z-0467-2008 | Hipstar V40 Femoral Stem-127 degrees; N degrees 3 high offset 31 mm;Catalog No... | Howmedica Osteonics Corp | LPH | ||
| Z-0466-2008 | Hipstar V40 Femoral Stem 127 degrees; N degrees 3 high offset 31 mm;Catalog No... | Howmedica Osteonics Corp | LPH | ||
| Z-0465-2008 | Hipstar V40 Femoral Stem-127 degrees; N degrees 3 high offset 31 mm; Catalog... | Howmedica Osteonics Corp | LPH | ||
| Z-0464-2008 | Hipstar V40 Femoral Stem-127 degrees; N degrees 3 high offset 31 mm; Catalog No... | Howmedica Osteonics Corp | LPH | ||
| Z-0475-2008 | Hipstar TMZF Cementless Hip Stem Protocol, Product Number: LSP60. | Howmedica Osteonics Corp | LPH | ||
| Z-0674-2008 | Orthofix TrueLok External Ring Fixation System, Telescopic Linear Distractor, Threaded in... | Orthofix SRL | LXT | ||
| Z-0278-2008 | Straumann Palatal Implant , 4.8 L 4.2 mm, Article Number: 042.336S, Straumann USA., LLC... | Straumann USA, LLC | OAT | ||
| Z-0277-2008 | Straumann Palatal Implant , 04.1 L 4.2 mm, Article Number: 042.335S, Straumann USA., LLC... | Straumann USA, LLC | OAT | ||
| Z-0463-2008 | Hipstar V40 Femoral Stem-127 degrees; Catalog No: 7850-5-001, N degrees 3 high offset 31... | Howmedica Osteonics Corp | LPH | ||
| Z-0676-2008 | Philips Medical Systems -- Cardiac Viewer or Pulmonary Viewer software application... | Philips North America LLC | KPS | ||
| Z-1396-2009 | Access Myoglobin Reagents Kits, Part Number: 973243. The Access Myoglobin assay is a... | Siemens Healthcare Diagnostics Inc. | DDR | ||
| Z-0447-2008 | Dale 242 Blue (Neonate, Infants and Small Children) Tracheostomy Tube Holder, Product... | Dale Medical Products, Inc. | CBH | ||
| Z-0446-2008 | Dale 240 Blue (Adults) Tracheostomy Tube Holder, Product Number: H84102401, Dale Medical... | Dale Medical Products, Inc. | CBH | ||
| Z-0214-2008 | Stryker T2 Locking Screw, Fully threaded; 05 x 70mm, Catalog Number: 1896-5070S, Sterile... | Howmedica Osteonics Corp | |||
| Z-0355-2008 | Arthrocare 6.5 mm ParaSorb, Preloaded with 2 MagnumWire sutures (1 white/1 co-braid) with... | TORNIER Inc. | MBI | ||
| Z-0354-2008 | Arthrocare 6.5 mm ParaSorb, Preloaded with 2 MagnumWire sutures (1 white/1 co-braid)... | TORNIER Inc. | MBI | ||
| Z-0353-2008 | Arthrocare 5.5mm ParaSorb, pre-loaded with 2 MagnumWire sutures (1 white/1 co-braid) with... | TORNIER Inc. | MBI | ||
| Z-0352-2008 | Arthrocare 5.5mm ParaSorb, pre-loaded with 2 MagnumWire sutures (1 white/1 co-braid)... | TORNIER Inc. | MBI | ||
| Z-0351-2008 | Arthrocare 3.0mm ParaSorb, Preloaded with 2 MagnumWire sutures (1 white/1 co-braid), Part... | TORNIER Inc. | MBI | ||
| Z-0350-2008 | Arthrocare 6.5mm ParaFix Anchor, 2 strands of MagnumWire Part Number: 22-5012, Axya... | TORNIER Inc. | MBI | ||
| Z-0349-2008 | Arthrocare 5mm ParaFix Anchor, 2 strands of MagnumWire Part Number: 22-5011, Axya... | TORNIER Inc. | MBI | ||
| Z-0348-2008 | Arthrocare 3mm ParaFix Anchor, single strand of Magnum Wire,Part Number: 22-5010, Axya... | TORNIER Inc. | MBI | ||
| Z-0347-2008 | Arthocare 3mm ParaFix Anchor (3mm x 9mm) -single strand of #2 braided suture,Part... | TORNIER Inc. | MBI | ||
| Z-0346-2008 | Arthocare 5mm ParaFix Anchor (5mm x 14.5mm) -2 strands of #2 braided suture, Part... | TORNIER Inc. | MBI | ||
| Z-0345-2008 | Axya Bone Anchor 3.0 mm Bioabsorbable in Super Kit Catalog Number: CAT1273, Axya Medical... | TORNIER Inc. | MBI | ||
| Z-0344-2008 | Axya Bone Anchor, 5.0 mm Bioabsorbable in Super Kit, Catalog Number: CAT1271, Axya... | TORNIER Inc. | MBI | ||
| Z-0343-2008 | Axya Bone Anchor 5.0 mm Bioabsorbable with UHMWPE Suture, Catalog Number: CAT1267, Axya... | TORNIER Inc. | MBI | ||
| Z-0342-2008 | Axya Bone Anchor 3.0 mm Bioabsorbable with UHMWPE Suture,Catalog Number: CAT1266, Axya... | TORNIER Inc. | MBI | ||
| Z-0341-2008 | Axya Bone Anchor 6.5 mm Bioabsorbable with Nylon Suture Catalog Number: CAT1265, Axya... | TORNIER Inc. | MBI | ||
| Z-0340-2008 | Axya Bone Anchor 6.5 mm Bioabsorbable with UHMWPE Suture,Catalog Number: CAT1264, Axya... | TORNIER Inc. | MBI | ||
| Z-0339-2008 | Axya Bone Anchor 5.0 mm Bioabsorbable with Nylon Suture Catalog Number: CAT1234, Axya... | TORNIER Inc. | MBI | ||
| Z-0338-2008 | Axya Bone Anchor, 3.0 mm Bioabsorbable with Nylon Suture Catalog Number: CAT1230, Axya... | TORNIER Inc. | MBI | ||
| Z-0337-2008 | Axya Bone Anchor 3.0 mm Titanium in Super Kit Catalog Number: CAT1274, Axya Medical... | TORNIER Inc. | MBI |