Events

Rappel de Device Recall Cane

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Invacare Corporation.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    63775
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0556-2013
  • Date de mise en oeuvre de l'événement
    2012-11-06
  • Date de publication de l'événement
    2012-12-18
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-08-20
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114753
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Cane, safety walk - Product Code KHY
  • Cause
    Following their receipt of several customer complaints, invacare recalled their height adjustable walking canes. the device was recalled from distribution based on reports indicating that there is a possibility that the button which holds the cane at the desired height, may suddenly and unexpectedly compress, causing the cane to collapse and cause possible injury to the user.
  • Action
    The firm, Invacare, sent an "URGENT MEDICAL DEVICE RECALL (Removal)" letter dated November 6, 2012 to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to examine their existing stock using the enclosed detailed 'Product Tracking Sheet' and quarantine any affected canes; Acknowledge receipt and understanding of the urgent recall notice and indicate the number of canes remaining in inventory on the enclosed, 'Provider Response Card;'. Fax the completed Provider Response Card to Invacare Regulatory Affairs at: 1- 440-326-3544; disassemble each cane and discard both pieces in the trash; (Disassembly instructions are also provided); and lastly, contact Invacare Customer Service at 1-800-668-2337, Monday - Friday, 8 a.m. - 8 p.m. EST, to order replacement merchandise at no charge. If you have any questions concerning these instructions, contact Invacare Customer Service at 1-800-668-2337, Monday - Friday, 8 a.m. - 6 p.m. ET.

Device

Device Recall Cane
  • Modèle / numéro de série
    The Lot Codes subject to recall are: PW111201, PW120201, PW120101, PW120301, and PW120401
  • Classification du dispositif
    Physical Medicine Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN KS, KY, LA,MA, MD ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH,OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY; and countries of: Australia, Puerto Rico, and Taiwan Province of China.
  • Description du dispositif
    Invacare Height Adjustable (walking) Canes, Model Numbers: 8916, 8917, and 40918-6. The device is packaged six (6) canes per shipping carton. || The cane is used as an aid in walking or ambulation.
  • Manufacturer
    Invacare Corporation

Manufacturer

Invacare Corporation
  • Adresse du fabricant
    Invacare Corporation, 1200 Taylor St, Elyria OH 44035-6248
  • Société-mère du fabricant (2017)
    Invacare Corporation
  • Source
    USFDA