Events

Device Recall Phantom Fiber Biofiber Sutures 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Tornier, Inc 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    79373
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1374-2018
  • 사례 시작날짜
    2018-02-08
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162146
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Suture, recombinant technology - Product Code NWJ
  • 원인
    Data has shown that degradation of a raw material used in phantom fiber may occur more quickly than expected if improperly stored. this may impact the shelf-life of the product which could cause the suture to lose strength more quickly than expected.
  • 조치
    The firm, Wright, sent an "Urgent Field Safety Notice" letter by email on 02/08/2018. The firm followed up with a letter on April 02, 2018 disseminated by FedEx Priority mail to their customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following actions: " Cease using the affected devices immediately. " Medical facilities are to determine if any of the recalled implants are on hand, and return affected implants immediately to Wright Medical. "Review the notice and complete the Acknowledgement Section Attachment C to signify that your facility has been informed of this Field Safety Notice (Recall). " Return the completed Acknowledgement to Wright Medical via email to: FieldAction@wright.com within five (5) working days of this notice. "Contact customer service at 1-888-494-7950 to facilitate any product returns. For any inquiries regarding the Phantom Fiber Field Safety Notice (Recall) contact: Wright Medical Quality Systems Manager by Email: FieldAction@wright.com or Phone: 952.683.7482.

Device

Device Recall Phantom Fiber Biofiber Sutures
  • 모델명 / 제조번호(시리얼번호)
    All lots
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 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
    Tornier, Inc

Manufacturer

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