3 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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ABC PROBE REF 160636 5 mm Handswitching Probe, 36 cm QTY: 1 STERILE CONMED CORPORATION 525 French Rd, Utica, NY 13502 ASSEMBLED IN MEXICO ABC PROBE REF 160636 5 mm Handswitching Probe, 36 cm QTY: 10 STERILE CONMED CORPORATION 525 FRENCH RD UTICA, NY 13502 ASSEMBLED IN MEXICO Usage: Electrosurgical handpiece for use as monopolar electrosurgical accessory in conjunction with CONMED electrosurgical units equipped with argon beam coagulation.
FDA Recall
Terminated
·ConMed Electrosurgery·Product code GEI·December 18, 2008
ABC PROBE REF 160644 5 mm Handswitching Probe, 44 cm QTY: 1 STERILE CONMED CORPORATION 525 French Rd, Utica, NY 13502... ASSEMBLED IN MEXICO ABC PROBE REF 160636 5 mm Handswitching Probe, 44 cm QTY: 10 STERILE CONMED CORPORATION 525 FRENCH RD UTICA, NY 13502 ASSEMBLED IN MEXICO Usage: Electrosurgical handpiece for use as monopolar electrosurgical accessory in conjunction with CONMED electrosurgical units equipped with argon beam coagulation.
FDA Recall
Terminated
·ConMed Electrosurgery·Product code GEI·December 18, 2008
Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012