Events

RSP Humeral Socket Reamer (Size 32 SML) 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Encore Medical, Lp 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
    59991
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0150-2012
  • 사례 출판 날짜
    2011-11-02
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-03-29
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104281
  • 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
    Orthopedic manual surgical instrument - Product Code LXH
  • 원인
    Djo surgical has determined that the alignment pins cannot be consistently cleaned using the technique provided in the cleaning/sterilization section of the instrument ifu.
  • 조치
    DJO Surgical sent an URGENT FIELD SAFETY NOTICE letter dated September 28, 2011, to all affected customers. The letter identified the product. the problem, and the action to be taken by the customer. Customers were instructed to return the RSP Humeral Socket Reamers and RSP Baseplate Rim Planers. The RSP Humeral Socket Reamers will be reworked and returned to the customer. The Baseplast Rim Planer will be replaced when a suitable design is available. During the interim until instruments are returned, the use of FMP acetabular reamers size 42mm, 43mm, 45mm (DJO PIN 803-05-226, 227, 200) for the humeral preparation was validated to be effective to prepare the humerus for the implant. Customers were instructed to immediately notify the hospitals and surgeons using these devices and document it on the Field Safety Notice Response Form. For questions regarding this recall call 512-832-9500.

Device

RSP Humeral Socket Reamer (Size 32 SML)
  • 모델명 / 제조번호(시리얼번호)
    All lots are being recalled.  DJO Surgical Part Number 804-02-013, 804-02-014, and 804-02-015
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA including AR, AZ, CA, CO, FL,GA, ID, IN, IL, LA, MA, MD, ME, MI, MO, NJ, NM, NY, OH, OK, PA, PR, SC, TN, TX, UT, VA, WA, and WI and Internationally toGermany, South America, Italy, Saudi Arabia, United Kingdom, and Canada.
  • 제품 설명
    RSP Humeral Socket Reamer (Size 32 SML): || DJO Surgical Instruments and Instrument Cases || DJO surgical || Encore Medical, L.P. 9800 Metric Blvd, Austin, TX 78758 || Contact information: DJO Surgical, ATTN: Customer Service, 9800 Metric Blvd, Austin, TX 78758, 1-800-456-8696. || The product is intended to be used to ream prepare the humeral bone for accepting the implant. It has a spring loaded alignment pin on the proximal (reaming) end used in both alignment of the reamer and as an indication that the reamer has been seated fully.
  • Manufacturer
    Encore Medical, Lp

Manufacturer

Encore Medical, Lp
  • 제조사 주소
    Encore Medical, Lp, 9800 Metric Blvd, Austin TX 78758
  • Source
    USFDA