Events

Osteoraptor Suture Anchor 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Smith & Nephew, Inc. Endoscopy Division 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
    66037
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2220-2013
  • 사례 시작날짜
    2013-08-06
  • 사례 출판 날짜
    2013-09-17
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-04-20
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121329
  • 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
    Staple, fixation, bone - Product Code JDR
  • 원인
    Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
  • 조치
    Smith&Nephew; sent an Urgent Product Recall Notification letter dated August 6, 2013, via Federal Express to all affected customers. Addendum customer letters for 4 additional part numbers were sent via Federal Express on August 19, 2013, The letters identified the product, the problem, and the action to be taken by the customer. Customers were asked to inspect their inventory, locate unused devices and quarantine them. Customers were also asked to complete the last three columns in the inventory Return Certification form indicating the quantities that need to be returned, and include their contact information in the spaces provided. Customers were instructed to contact Smith & Nephew's Demo Service Departmentat 800-343-5717 for a Return Authorization (RA#), and provide the information response form. Replacement product would be provided. For questions regarding this recall call 978-749-1073.

Device

Osteoraptor Suture Anchor
  • 모델명 / 제조번호(시리얼번호)
    50261071 50265227 50268236 50270124 50270127 50270731 50270732 50270944 50272331 50272463 50272751 50274143 50274349 50277106 50278834 50281659 50282211 50282825 50283848 50285062 50287130 50288422 50289369 50291056 50292247 50293722 50295044 50295954 50297046 50298435 50299024 50301146 50301385 50302078 50306608 50307181 50307859 50308888 50308912 50309137 50311191 50312587 50314102 50315238 50316441 50316664 50317482 50317875 50318971 50319908 50320248 50321101 50321648 50322088 50322930 50323639 50324385 50325610 50325737 50326879 50327995 50328245 50329009 50329813 50330435 50332245 50333093 50333956 50334115 50334402 50335321 50336229 50336882 50337043 50337449 50338243 50338995 50339833 50340161 50341063 50341287 50341846 50342910 50343441 50344016 50344263 50344619 50346628 50347009 50347537 50348331 50349439 50350189 50350979 50351681 50351959 50352540 50353155 50353497 50353607 50354099 50355298 50355824 50356121 50356985 50357105 50357560 50358205 50358555 50359713 50360281 50360451 50361177 50362090 50362645 50362978 50363189 50363545 50364184 50364663 50364910 50364911 50364912 50369681 50369960 50370096 50370209 50371913 50373322 50373580 50374378 50375175 50375582 50375896 50376045 50376616 50376834 50377164 50377317 50379208 50379388 50379938 50380822 50381057 50381374 50381815 50382801 50383513 50384164 50384951 50385489 50385824 50386925 50387321 50387880 50387895 50388430 50389103 50390008 50390942 50391228 50391627 50392267 50392391 50393196 50393760 50394180 50396181 50396831 50397271 50397460 50398372 50398722 50399414 50399815 50400186 50400942 50401453 50401757 50401920 50402611 50402824 50403368 50403711 50403712 50404421 50404748 50405574 50406025 50406508 50407109 50407568 50408211 50408883 50410215 50409543 50409822 50410771 50411055 50412025 50412274 50412888 50413142 50413774 50414255 50414556 50415255 50415495 50415667 50415868 50416318 50416532 50416826 50417010 50417205 50417523 50418332 50419700 50420159 50420854 50421718 50423590 50423955 50425117 50426327 50426461 50426940 50427506 50427629 50428458 50428810 50430183 50430401 50430506 50430507 50430658 50430659 50430660 50430661 50431124 50431125 50431126 50431237 50431238 50431383 50431385 50433042 50433340 50435317 50435735 50436891 50437525 50437584 50438203 50438660 50438927 50439573 50439897 50440453 50441440 50441678 50442126 50442378 50444664 50445032 50445140 50445313 50445546 50445547 50446664 50447263 50448058 50448322 50448831 50450467 50450753 50450948 50451767 50451782 50452211 50452586 50453147 50453807 50454296 50454419 50454689 50455196 50455484 50455814 50456055 50456612 50456911 50457054 50457927 50458417 50458476 50459149 50459444 50460099 50460241 50461693 50461911 50462227 50462795 50463367 50463459
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - USA (nationwide) Canada, Europe: Austria, Belgium, Cyprus, Czech Republic, Denmark, Germany, Greece, Finland, France, Italy, Ireland, Luxembourg, Netherlands, Norway, Poland, Portugal, Russia, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine and United Kingdom, Asia-pacific: Australia, China, Dubai, Hong Kong, India, Japan, Malaysia, New Zealand, Philippines, Sri Lanka, Singapore, South Korea, Taiwan, Thailand, Argentina, Bermuda, Brazil, Chile, Colombia, Costa Rica, Israel, Mexico, Puerto Rico, South Africa, and Venezuela.
  • 제품 설명
    OSTEORAPTOR 2.3 mm Suture Anchor with ULTRABRAID COBRAID Suture, Blue; Part Number: 72201993 || Biodegradable suture anchor
  • Manufacturer
    Smith & Nephew, Inc. Endoscopy Division

Manufacturer

Smith & Nephew, Inc. Endoscopy Division
  • 제조사 주소
    Smith & Nephew, Inc. Endoscopy Division, 150 Minuteman Drive, Andover MA 01810-1031
  • Source
    USFDA