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-1254-2013 | Class III | Mercury Spinal System DIA 5.5 x 110mm Lordosed Rod, Part Number: 60100-110. Intended to... | Spinal Elements, Inc | NKB | |
| Z-1253-2013 | Class III | Mercury Spinal System DIA 5.5 x 100mm Lordosed Rod, Part Number: 60100-100. Intended to... | Spinal Elements, Inc | NKB | |
| Z-1252-2013 | Class III | Mercury Spinal System DIA 5.5 x 90 MM Lordosed Rod, Part Number: 60100-090. Intended to... | Spinal Elements, Inc | NKB | |
| Z-1251-2013 | Class III | Mercury Spinal System DIA 5.5 x 80 MM Lordosed Rod, Part Number: 60100-080. Intended to... | Spinal Elements, Inc | NKB | |
| Z-1250-2013 | Class III | Mercury Spinal System DIA 5.5 x 70 MM Lordosed Rod, Part Number: 60100-070. Intended to... | Spinal Elements, Inc | NKB | |
| Z-1249-2013 | Class III | Mercury Spinal System DIA 5.5 x 60 MM Lordosed Rod, Part Number: 60100-060. Intended to... | Spinal Elements, Inc | NKB | |
| Z-1248-2013 | Class III | Mercury Spinal System DIA 5.5 x 50 MM Lordosed Rod, Part Number: 60100-050. Intended to... | Spinal Elements, Inc | NKB | |
| Z-1247-2013 | Class III | Mercury Spinal System DIA 5.5 x 40 MM Lordosed Rod, Part Number: 60100-040. Intended to... | Spinal Elements, Inc | NKB | |
| Z-1246-2013 | Class III | Mercury Spinal System DIA 5.5 x 30 MM Lordosed Rod, Part Number: 60100-030. Intended to... | Spinal Elements, Inc | NKB | |
| Z-2040-2009 | Leckey 4-Point Pelvic Harness Belts, catalog 081326990; James Leckey Design Ltd., Kilwee... | Patterson Medical Holdings, Inc. | INN | ||
| Z-1523-2009 | Zimmer NexGen Complete Knee Solution Legacy Knee- Posterior Stabilized LPS Femoral... | Zimmer GmbH | NJL | ||
| Z-1522-2009 | Zimmer NexGen Complete Knee Solution Legacy Knee- Posterior Stabilized LPS-FLEX Femoral... | Zimmer GmbH | NJL | ||
| Z-1521-2009 | Zimmer NexGen Complete Knee Solution Legacy Knee- Posterior Stabilized LPS-FLEX Femoral... | Zimmer GmbH | NJL | ||
| Z-1520-2009 | Zimmer NexGen Complete Knee Solution Legacy Knee - Posterior Stabilized LPS-Flex Femoral... | Zimmer GmbH | NJL | ||
| Z-1597-2009 | ASC2000 Ambulatory Surgical Table. Model #MTS110003. The device is used to provide... | STERIS Corporation | GDC | ||
| Z-0487-2012 | Harmonie software in use with: Harmonie-E Long Term Monitoring System (Models... | Stellate Systems | GWQ | ||
| Z-2028-2009 | Diamondback 360 Orbital Atherectomy Device, 1.50 LT Classic, Model #DB-150L, CSI Part #... | Cardiovascular Systems Incorporated | MCW | ||
| Z-1610-2009 | Offset Adaptor Trial - 8MM, Triathlon Revision Instruments. Non-Sterile; Howmedica... | Howmedica Osteonics Corp | JWH | ||
| Z-1609-2009 | Offset Adaptor Trial - 6MM, Triathlon Revision Instruments. Non-Sterile; Howmedica... | Howmedica Osteonics Corp | JWH | ||
| Z-1608-2009 | Offset Adaptor Trial - 4MM, Triathlon Revision Instruments. Non-Sterile; Howmedica... | Howmedica Osteonics Corp | JWH | ||
| Z-1607-2009 | Offset Adaptor Trial - 2MM, Triathlon Revision Instruments. Non-Sterile; Howmedica... | Howmedica Osteonics Corp | JWH | ||
| Z-0138-2010 | Innova 2121-IQ/3131-IQ Biplane Cardiovascular Imaging System. | GE Healthcare | JAA | ||
| Z-0137-2010 | GE Healthcare, GE Innova 4100 / 4100 IQ. , ( The system consists of an a monoplane... | GE Healthcare | IYO | ||
| Z-0136-2010 | GE Healthcare, GE Innova 2100 IQ Versatile Cardiac and Vascular Imaging System, (The... | GE Healthcare | IZI | ||
| Z-0135-2010 | GE Healthcare, GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, (The system... | GE Healthcare | MQB | ||
| Z-1557-2009 | GE Signa OpenSpeed 0.7T MR System. The 0.7T Signa OpenSpeed with Excite Magnetic... | GE Healthcare | LNH | ||
| Z-1556-2009 | GE Signa Ovation 0.35 T MR System. The Signa Ovation System is an open, whole body... | GE Healthcare | LNH | ||
| Z-1554-2009 | Waste bottles Part Numbers/Article Numbers: 905-590/D512 and 905-802/D513. The waste... | Radiometer America, Inc | CHL | ||
| Z-1435-2011 | IMPAX CV Results Manager/Results Manager Administration Tool The IMPAX Cardiovascular... | AGFA Healthcare Corp. | LLZ | ||
| Z-1461-2010 | Freestyle Navigator Continuous Glucose Monitor System, Clinical Transmitter, Abbott Item... | Abbott Medical | MDS | ||
| Z-1460-2010 | Freestyle Navigator Continuous Glucose Monitor System, Assy, Transmitter Poly Contac... | Abbott Medical | MDS | ||
| Z-1459-2010 | Freestyle Navigator Continuous Glucose Monitor System, ABB Transmitter Navigator... | Abbott Medical | MDS | ||
| Z-1458-2010 | Freestyle Navigator Continuous Glucose Monitor System, Clinical System Kit, Packaging... | Abbott Medical | MDS | ||
| Z-1457-2010 | Freestyle Navigator Continuous Glucose Monitor System, System Kit, Business 1, (Orange)... | Abbott Medical | MDS | ||
| Z-1456-2010 | Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, System Kit MG... | Abbott Medical | MDS | ||
| Z-1455-2010 | Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, System Kit MMOL... | Abbott Medical | MDS | ||
| Z-1454-2010 | Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, System Kit MMOL... | Abbott Medical | MDS | ||
| Z-1453-2010 | Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, System, Business... | Abbott Medical | MDS | ||
| Z-1438-2010 | 2.0/2.4 Cannulated Screw Driver Bit, part #210-24-003 | Trilliant Surgical LLC | HWC | ||
| Z-1452-2010 | Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, System, Business... | Abbott Medical | MDS | ||
| Z-1451-2010 | Freestyle Navigator Continuous Glucose Monitor System, ABB NAV Dutch System Kit CE RE... | Abbott Medical | MDS | ||
| Z-1450-2010 | Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, System Kit... | Abbott Medical | MDS | ||
| Z-1449-2010 | Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, System Kit... | Abbott Medical | MDS | ||
| Z-1448-2010 | Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, ABB System Kit... | Abbott Medical | MDS | ||
| Z-1447-2010 | Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, Reorder/Warranty... | Abbott Medical | MDS | ||
| Z-1446-2010 | Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, Replacement Kit... | Abbott Medical | MDS | ||
| Z-1445-2010 | Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, ABB Warranty Kit... | Abbott Medical | MDS | ||
| Z-1444-2010 | Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, SYSTEM KIT... | Abbott Medical | MDS | ||
| Z-0821-2010 | Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, SYSTEM KIT... | Abbott Medical | MDS | ||
| Z-0820-2010 | Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, ABB SYSTEM... | Abbott Medical | MDS |