Events

Versys 6 inch Beaded Full Coat Plus Hip Prosthesis. 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Zimmer Biomet, 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
    78762
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0722-2018
  • 사례 시작날짜
    2017-08-01
  • 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=161178
  • 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
    Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
  • 원인
    The products being recalled exceeded the weight previously tested leading to a possibility of damage to the package and/or a compromised sterile barrier.
  • 조치
    The firm, Zimmer Biomet, sent an "URGENT MEDICAL DEVICE RECALL REMOVAL"-Lot Specific letter dated 8/1/2017 to its Customers via email and/or FedEx. The letter describes the product, problem and actions to be taken. The Instructions to Distributors, Sales Representatives, and Distributor Operation Managers included to ensure affected team member are aware of the contents of the notification letter, immediately locate and quarantine affected product in inventory, complete and return the Certification of Acknowledgement form by email to: corporatequality.postmarket@zimmerbiomet.com., return all affected product, and note if there are any hospitals and/or surgeons for which need to be notified. Instructions for Risk Managers and surgeons are to ensure affected personnel are aware of the contents of the notification letter, quarantine any affected product on hand, complete and return the Certificate of Acknowledgement form by email to: corporatequality.postmarket@zimmerbiomet.com., and return any affected product on hand. For questions or concerns, please call the 411 call center at 1-574-371-3071 between 8:00 am and 5:00 pm EST, Monday through Friday or email corporatequality.postmarket@zimmerbiomet.com

Device

Versys 6 inch Beaded Full Coat Plus Hip Prosthesis.
  • 모델명 / 제조번호(시리얼번호)
    a. Item No. 00784301906 (Lot Expiration Date Before 05/31/2025);  b. Item No. 00784302106 (Lot Expiration Date Before 06/30/2025);  c. Item No. 00784302206 (Lot Expiration Date Before 01/31/2026);  d. Item No. 00784301936 (Lot Expiration Date Before 06/30/2026);  e. Item No. 00784302036 (Lot Expiration Date Before 01/31/2026);  f. Item No. 00784302136 (Lot Expiration Date Before 02/28/2025);  g. Item No. 00784302236 (Lot Expiration Date Before 07/31/2026);  h.Item No. 00784301406 (Lot Expiration Date Before 07/31/2026);  i. Item No. 00784301506 (Lot Expiration Date Before 06/30/2026);  j. Item No. 00784301606 (Lot Expiration Date Before 06/30/2026);  k. Item No. 00784301706 (Lot Expiration Date Before 06/30/2026);  l. Item No. 00784301806 (Lot Expiration Date Before 03/31/2026);  m. Item No. 00784301826 (Lot Expiration Date Before 04/30/2026);  n. Item No. 00784301926 (Lot Expiration Date Before 11/30/2025);  o. Item No. 00784302006 (Lot Expiration Date Before 11/30/2025);  p. Item No. 00784302026 (Lot Expiration Date Before 07/31/2026);  q. Item No. 00784302126 (Lot Expiration Date Before 07/31/2026);  r. Item No. 00784302226 (Lot Expiration Date Before 09/30/2025);  s. Item No. 00784301746 (Lot Expiration Date Before 07/31/2026);  t. Item No. 00784301756 (Lot Expiration Date Before 07/31/2025):  u. Item No. 00784301836 (Lot Expiration Date Before 07/31/2026);  v. Item No. 00784301846 (Lot Expiration Date Before 07/31/2026);  w. Item No. 00784301856 (Lot Expiration Date Before 06/30/2026);  x. Item No. 00784301946 (Lot Expiration Date Before 07/31/2026);  y. Item No. 00784301956 (Lot Expiration Date Before 09/30/2025);  z. Item No. 00784302046 (Lot Expiration Date Before 07/31/2026);  aa.Item No. 00784302056 (Lot Expiration Date Before 07/31/2026);  ab. Item No. 00784302146 (Lot Expiration Date Before 07/31/2026);  ac. Item No. 00784302156 (Lot Expiration Date Before 07/31/2026);  ad. Item No. 00784302246 (Lot Expiration Date Before 07/31/2026);  ae. Item No. 00784302256 (Lot Expiration Date Before 07/31/2026)
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution: US (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, and Puerto Rico; and to countries of: Austria, Australia, Bahamas, Brazil, Canada, China, Dominican Republic, England, France, Germany, Israel, Japan, South Korea, Lebanon, Malaysia, Mexico, Netherlands, Panama, Singapore, Spain, Switzerland, and Thailand.
  • 제품 설명
    Versys 6 inch Beaded Full Coat Plus Hip Prosthesis. Labeled as follows: || a. VERSYS 6 INCH BEADED FC 19X160MM STD BODY STD NECK (Item No. 00894301906); || b. VERSYS 6 INCH BEADED FC 21X160MM STD BODY STD NECK (Item No. 00784302106); || c. VERSYS 6 INCH BEADED FC 22X160MM STD BODY STD NECK (Item No. 00784302206); || d. VERSYS 6 INCH BEADED FC STEM 19X160MM LM (Item No. 00784301936); || e. VERSYS 6 INCH BEADED FC STEM 20X160MM LM (Item No. 00784302036); || f. VERSYS 6 INCH BEADED FC STEM 21X160MM LM (Item No. 00784302136); || g. VERSYS 6 INCH BEADED FC STEM 22X160MM LM (Item No. 00784302236); || h. VERSYS 6 INCH BEADED FC 14X160MM STD BODY STD NECK (Item No. 00784301406); || i. VERSYS 6 INCH BEADED FC 15X160MM STD BODY STD NECK (Item No. 00784301506); || j. VERSYS 6 INCH BEADED FC 16X160MM STD BODY STD NECK (Item No. 00784301606); || k. VERSYS 6 INCH BEADED FC 17X160MM STD BODY STD NECK (Item No. 00784301706); || l. VERSYS 6 INCH BEADED FC 18X160MM STD BODY STD NECK (Item No. 00784301806); || m. VERSYS 6 INCH BEADED FC 18X160MM STD BODY EXT NECK (Item No. 00784301826); || n. VERSYS 6 INCH BEADED FC 19X160MM STD BODY EXT NECK (Item No. 00784301926); || o. VERSYS 6 INCH BEADED FC 20X160MM STD BODY STD NECK (Item No. 00784302006); || p. VERSYS 6 INCH BEADED FC 20X160MM STD BODY EXT NECK (Item No. 00784302026); || q. VERSYS 6 INCH BEADED FC 21X160MM STD BODY EXT NECK (Item No. 00784302126); || r. VERSYS 6 INCH BEADED FC 22X160MM STD BODY EXT NECK (Item No. 00784302226); || s. VERSYS 6 INCH BEADED FC 17X160MM LM BODY XEXT NECK (Item No. 00784301746); || t. VERSYS 6 INCH BEADED FC 17X160MM LM BODY EXT NECK (Item No. 00784301756 || u. VERSYS 6 INCH BEADED FC STEM 18X160MM LM (Item No. 00784301836); || v. VERSYS 6 INCH BEADED FC 18X160MM LM BODY XEXT NECK (Item No. 00784301846); || w. VERSYS 6 INCH BEADED FC 18X160MM LM BODY EXT NECK (Item No. 00784301856); || x. VERSYS 6 INCH BEADED FC 19X160MM LM BODY XEXT NECK (Item No. 00784301946); || y. VERSYS 6 INCH BEADED FC 19X160MM LM BODY EXT NECK (Item No. 00784301956); || z. VERSYS 6 INCH BEADED FC 20X160MM LM BODY XEXT NECK (Item No. 00784302046); || aa. VERSYS 6 INCH BEADED FC 20X160MM LM BODY EXT NECK (Item No. 00784302056); || ab. VERSYS 6 INCH BEADED FC 21X160MM LM BODY XEXT NECK (Item No. 00784302146); || ac. VERSYS 6 INCH BEADED FC 21X160MM LM BODY EXT NECK (Item No. 00784302156); || ad. VERSYS 6 INCH BEADED FC 22X160MM LM BODY XEXT NECK (Item No. 00784302246); || ae. VERSYS 6 INCH BEADED FC 22X160MM LM BODY EXT NECK (Item No. 00784302256) || Components of the system are intended to replace the proximal femur, mid-shaft femur, distal femur, proximal tibia, and/or total knee in cases that require extensive resection and restoration.
  • Manufacturer
    Zimmer Biomet, Inc.

Manufacturer

Zimmer Biomet, Inc.
  • 제조사 주소
    Zimmer Biomet, Inc., 1800 W Center St, Warsaw IN 46580-2304
  • 제조사 모회사 (2017)
    Zimmer Biomet Holdings
  • 제조사 의견
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    USFDA