Device Recall Stryker RadioCapitellum, Capitellum

  • 모델명 / 제조번호(시리얼번호)
    Part Number: 410-0000 (Radio Capitellum Large, Left) - Lot #'s 18832, 22193201, 22193202, 22193203, 22258301,22957101, 23853901, 19069-S2, 19077-S2 and 19155S2; Part Number: 410-0001 (Radio Capitellum Small, Left) - Lot #'s18833, 18834, 22193302, 22193303, 22766801, 2295601 and 23853101; Part Number: 410-0002 (Radio Capitellum Large, Right) - Lot #'s18835, 18836, 22193401, 22193402, 22193403, 22766901, 22956301, 23853201 and 19074-S2; Part Number: 410-0003 (Radio Capitellum Small, Right) - Lot #'s 18565, 22193501, 22193502, 22193503, 22767001, 22956401 and 23853301
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution.
  • 제품 설명
    Radio-Capitellum, Capitellum, Left, Large, Do Not Reuse, Rx Only. Indicated for use in the elbow for reduction or relief of pain and/or improved elbow function in skeletally mature patients.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Stryker Howmedica Osteonics Corp., 325 Corporate Dr, Mahwah NJ 07430-2006
  • 제조사 모회사 (2017)
  • Source
    USFDA