Events

Rappel de Device Recall Ossur Total Knee

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 Ossur North America Inc.

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
    35132
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1198-06
  • Date de mise en oeuvre de l'événement
    2006-03-29
  • Date de publication de l'événement
    2006-07-04
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2008-08-08
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45389
  • 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
    Joint, Knee, External Limb Component - Product Code ISY
  • Cause
    The company's initiation of the recall is based on a finding that some units of the total knee device may contain faulty pins based in the axis of the knee. small cracks propagate through the pin cross section until the pin breaks, severely compromising the knee function.
  • Action
    On 3/29/06 a press release was posted on OandP.com, an industry specific web site. An announcement listing involved serial numbers and contact phone numbers was also posted on the company''s web site, ossur.com. A two stage mailing has been constructed. The first letter sent to all customers March 30, 2006, describes the problem and models affected. The second letter, March 31, 2006, is customer specific and lists all of the involved serial numbers by model which were purchased by that customer. Telephone calls will be placed to customers who do not respond to the mailings.

Device

Device Recall Ossur Total Knee
  • Modèle / numéro de série
    Serial numbers: 14466 ¿ 16053 including the following repaired units outside the stated range. 12588, 13131, 13216, 13236, 13265, 13363, 13487, 13573, 13598, 13799, 13967, 14028, 14032, 14127, 14143, 14158, 14159, 14370.
  • Classification du dispositif
    Physical Medicine Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Distribution worldwide in Austria, Canada, Columbia, Hong Kong, Japan, Korea, Kuwait, Malaysia, Mexico, Taiwan, & New Zealand. Involved states are: AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, AND WY.
  • Description du dispositif
    Ossur Total Knee 1900, Model Number TK 1900, external prosthetic knee.
  • Manufacturer
    Ossur North America Inc

Manufacturer

Ossur North America Inc
  • Adresse du fabricant
    Ossur North America Inc, 27412 Aliso Viejo Pkwy, Aliso Viejo CA 92656-3371
  • Source
    USFDA