Events

Device Recall Abrader; AcromioBlaster; CoolCut; Dyonics; Elite; Formula; Gator; Great White; Incisor; RazorCut; Sy 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Surgical Instrument Service And Savings, 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
    65205
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1633-2013
  • 사례 시작날짜
    2013-05-03
  • 사례 출판 날짜
    2013-07-01
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-07-11
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118477
  • 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
    Arthroscope - Product Code HRX
  • 원인
    The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.
  • 조치
    MEDISISS sent a Correction Immediate Action Request letter dated May 2, 2013, to all affected customes. The letter identified the product, the problem, and the action to be taken by the customer. The letter directed the customer to inspect the products prior to use for seal integrity as specified on the product labeling: "Sterile unless package has been damaged or opened. Do not use if package is damaged." This will be followed up by a visit from the customer's sales representatives who are tasked with inspecting all the lots that may be remaining in the customer's inventory. The sales representative is directed to complete a "Verification of Seal Inspection" form and return it to MEDISISS Customer Relations. Devices with unacceptable seals are to be returned to MEDISISS. The sales representative is responsible for obtaining a shipping label from customer service to enable the devices to be returned to the recalling firm via Fed Ex. Customers with questions were instructed to call 866-866-7477.

Device

Device Recall Abrader; AcromioBlaster; CoolCut; Dyonics; Elite; Formula; Gator; Great White; Inc...
  • 모델명 / 제조번호(시리얼번호)
    122590, 122338, 123263, 122347, 123190, 122493, 122594, 122592, 122482, 122490, 122631, 122289, 123353, 122609, 122465, 122440, 123270, 122588, 122518, 122309, 122279, 122278, 122434, 122665, 122511.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution.
  • 제품 설명
    - Abrader Bur, Round (Aqua) 4.0mm Ref. 7205324 Lot 123270 || - AcromioBlaster Burr (Brick Red) 5.5mm Ref. 7205669 Lot 122590, 122454, 122465, 122434, 122665 || - AcromioBlaster Burr (Sage Green) 4.0mm Ref. 7205668 Lot 122590, 123270 || - Acromionizer Bur, Barrel, (Mauve) 4.0mm Ref. 7205326 Lot 122609 || - BoneCutter Blade, Full Radius, Series 3000 (Orange/Black) 5.5mm Ref. 7206010 Lot 122609 || - CoolCut Bone Cutter (Blue/Orange) 3.8mm Ref. AR-8380BC Lot 122631 || arthoscope || - CoolCut Bone Cutter (Blue/Orange) 4.0mm Ref. AR-8400BC Lot 122631 || - CoolCut Bone Cutter (Blue/Orange) 5.5mm Ref. AR-8550BC Lot 122631 || - CoolCut Dissector (Blue/Blue) 3.5mm Ref. AR-8350DS Lot 123190 || - CoolCut Dissector (Blue/Blue) 4.0mm Ref. AR-8400DS Lot 123190, 122493, 122631 || - CoolCut Dissector (Blue/Blue) 5.0mm Ref. AR-8500DS Lot 122493 || - CoolCut Dissector Small Joint (Blue/Blue) 3.0mm Ref. AR-7300DS Lot 123190, 122493, 122631, || - CoolCut Excalibur (Blue/Beige) 3.8mm Ref. AR-8380EX Lot 122631 || - CoolCut Excalibur (Blue/Beige) 4.0mm Ref. AR-8400EX Lot 122631 || - CoolCut Oval Burr (12 Flutes) (Blue/White) 5.5mm Ref. AR-8550OBT Lot 122631 || - CoolCut Oval Burr (8 Flute) (Blue/White) 4.0mm Ref. AR-8400OBE Lot 122493, 122631, 122279 || - CoolCut Oval Burr (8 Flute) (Blue/White) 5.0mm Ref. AR-8500OBE Lot 122493 || - CoolCut Round Burr (8 Flute) (Blue/Red) 5.0mm Ref. AR-8500RBE Lot 123190 || - CoolCut Sabre (Blue/Green) 3.8mm Ref. AR-8380SR Lot 122493 || - DYONICS ELITE Achromobacter (Sage Green) 4.0mm Ref. 72200730 Lot 122665 || - Elite* AcromioBlaster Burr (Brick Red/Yellow) 5.5mm Ref. 72200731 Lot 122665 || - Formula Aggressive Plus Cutter (Beige/Blue) 5.5mm Ref. 375-564-000 Lot 122309 || - Formula Aggressive Plus Cutter (Dk. Blue/Lt. Blue) 5.0mm Ref. 375-554-000 Lot 122490 || - Formula Aggressive Plus Cutter (Yellow/Blue) 3.5mm Ref. 375-534-000 Lot 122518, 122309 || - Formula Aggressive Plus Cutter Large Hub, (Red/Blue) 4.0mm Ref. 375-544-000 Lot 122594, 122588, 122518, 122278 || - Formula Barrel Bur, 12-Flute (Beige/Beige) 5.5mm Ref. 375-951-012 Lot 122278 || - Formula Barrel Bur, 12-Flute (Blue/Blue) 5.0mm Ref. 375-951-112 Lot 122594 || - Formula Barrel Bur, 12-Flute (Red/Red) 4.0mm Ref. 375-941-012 Lot 122594, 122518 || - Formula Barrel Bur, 6-Flute (Beige/Beige) 5.5mm Ref. 375-951-000 Lot 122588 || - Formula Barrel Bur, 6-Flute (Red/Red) 4.0mm Ref. 375-941-000 Lot 122588 || - Formula Full Radius Cutter, Small Joint, (Grey) 2.5mm Ref. 375-627-000 Lot 122594 || - Formula Hooded Abrasion Bur, Small Joint, (Orange) 3.0mm Ref. 375-647-000 Lot 122518 || - Formula Resector Cutter (Red/Black) 4.0mm Ref. 375-542-000 Lot 122588 || - Formula Resector Cutter (Yellow/Black) 3.5mm Ref. 375-532-000 Lot 122594, 122490, 122588 || - Formula Round Bur, 12-Flute (Beige/Beige) 5.5mm Ref. 375-950-012 Lot 122278 || - Formula Round Bur, 12-Flute (Red/Red) 4.0mm Ref. 375-940-012 Lot 122594 || - Formula Round Bur, 6-Flute (Blue/Blue) 5.0mm Ref. 375-950-100 Lot 122490 || - Formula Round Bur, 6-Flute (Red/Red) 4.0mm Ref. 375-940-000 Lot 122518 || - Formula Slotted Whisker (Red/Red) 4.0mm Ref. 375-548-000 Lot 122594 || - Formula Tomcat Cutter (Red/White) 4.0mm Ref. 375-545-000 Lot 122588 || - Formula Tomcat Cutter (Yellow/White) 3.5mm Ref. 375-535-000 Lot 122588 || - Full Radius Blade (Yellow) 4.5mm Ref. 7205306 Lot 122347, 122454, 122609, 123270, 122665 || - Full Radius Blade, (Beige) 3.5mm Ref. 7205305 Lot 122609, 122665 || - Full Radius Blade, (Orange) 5.5mm Ref. 7205307 Lot 122665 || - Full Radius ELITE Blade (Beige) 3.5mm Ref. 7210751 Lot 122465, 122665 || - Full Radius Mini Blade, 7cm Length (Red) 2.9mm Ref. 3419 Lot 122609 || - Full Radius Resector Large Hub, Sterling, Shaver, (Yellow) 4.2mm Ref. 9247A Lot 123263, 122592, 123353 || - Full Radius Resector, Large Hub, Merlin, Pre-Bent 15 Degree, (Yellow/Black) 4.2mm Ref. C9241 Lot 123263 || - Full Radius Resector, Sterling, Large Hub, (Yellow) 3.5mm Ref. C9248 Lot 123263, 122592, 122511 || - Gator B
  • Manufacturer
    Surgical Instrument Service And Savings, Inc.

Manufacturer

Surgical Instrument Service And Savings, Inc.
  • 제조사 주소
    Surgical Instrument Service And Savings, Inc., 2747 Sw 6th St, Redmond OR 97756-7109
  • 제조사 모회사 (2017)
    Medline Industries Inc.
  • Source
    USFDA