Device Recall USS Small Stature

  • 모델명 / 제조번호(시리얼번호)
    Part Numbers: 298.269 298.270 298.271 298.272 298.273 298.274 298.275 298.276 298.277 298.278  with lot numbers:  4729951; 4841209; 4923651; 4923652; 4987688; 4987750; 5350635; 2002330; 3000595 4729952; 4841210; 4923653; 4923654; 4987683; 4856248; 4987755; 5153848; 5153853; 1602596; 1880489 4729953; 4841211; 4923666; 4923667; 4987778; 4856275; 4987761; 5159826; 5157329; 3016224  4729954; 4841212; 4919162; 4923669; 4987779; 4856250; 4987766; 5153796; 3093619 4729956; 4923674; 4987825; 4987780; 5066363 4729958; 4923615; 4987826; 4987781; 5066364 4729959; 4841213; 4923655; 4936270; 4987684; 4987771; 5153849; 5153854 4729960; 4835367; 4923656; 4923657; 4984982; 4856246; 4987772; 5159827; 5157330  4729961; 4835368; 4923658; 4923659; 4987685; 4856249; 4987773; 1602617; 3080451 4729962; 4835378; 4919165; 4923660; 4987686; 4856252; 4987776; 5153851
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution.
  • 제품 설명
    5.0mm Unit Rod 270mm || 5.0mm Unit Rod 290mm || 5.0mm Unit Rod 310mm || 5.0mm Unit Rod 330mm || 5.0mm Unit Rod 350mm || 5.0mm Unit Rod 370mm || 5.0mm Unit Rod 390mm || 5.0mm Unit Rod 410mm || 5.0mm Unit Rod 430mm || 5.0mm Unit Rod 450mm || pedicle screw spinal system; || Intended to provide immobilization and stabilization of spinal segments in skeletally mature patients.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Synthes USA HQ, Inc., 1302 Wrights Ln E, West Chester PA 19380-3417
  • 제조사 모회사 (2017)
  • Source
    USFDA