Device Recall Phantom Fiber Biofiber Sutures

  • 모델명 / 제조번호(시리얼번호)
    All lots
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    US Nationwide Distribution.
  • 제품 설명
    Fornier Phantom Fiber(TM) Sutures: || Item Number Description || SMB000425 4.5 MM PHANTOM FT BIOCOMPOSITE SUTURE ANCHOR WITH NEEDLES || SMB000525 5.5 MM PHANTOM FT BIOCOMPOSITE SUTURE ANCHOR WITH NEEDLES || SMP000425 4.5 MM PHANTOM FT PEEK SUTURE ANCHOR WITH NEEDLES || SMP000525 5.5 MM PHANTOM FT PEEK SUTURE ANCHOR WITH NEEDLES || SMSB0110 1PK PHANTOM FIBER SZ 2 WHITE || SMSB0110N lPK BIOFIBER SUTURE SZ 2 WHT NEEDLED || SMSB0112 10 PK PHANTOM FIBER SZ 2 WHITE || SMSB0112N 10 PK PHANTOM FIBER SUTURE SZ 2WHT NEEDLED || SMSB0120 1PK PHANTOM FIBER SZ 2 VIOLET || SMSB0120N lPK BIOFIBER SUTURE SZ 2 VLT NEEDLED || SMSB0122 10 PK PHANTOM FIBER SZ 2 VIOLET || SMSB0122N 10 PK BIOFIBER SUTURE SZ 2 VLT NEEDLED || SMSB0130 1PK PHANTOM FIBER SZ 2 WHITE/VIOLET || SMSB0132 10 PK PHANTOM FIBER SZ 2 WHITE/VIOLET || Indications for use for the Phantom Fiber are: Phantom Fiber suture is indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Tornier, Inc, 10801 Nesbitt Ave S, Bloomington MN 55437-3109
  • 제조사 모회사 (2017)
  • Source
    USFDA