Events

Rappel de Device Recall STRYKERArthroscopic Burr

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 Ascent Healthcare Solutions.

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
    58937
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0960-2012
  • Date de mise en oeuvre de l'événement
    2009-01-26
  • Date de publication de l'événement
    2012-02-03
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-03-09
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105462
  • 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
    Arthroscope - Product Code HRX
  • Cause
    On 01/26/2009, ascent healthcare solutions, lakeland, fl initiated a recall of various models of dyonics, stryker, and linvatech reprocessed arthroscopic shaver blades. the sterility of the devices may be compromised due to a potential breach in the seal of the tyvek cover to the plastic tray.
  • Action
    Ascent Healthcare Solutions sent an "URGENT MEDICAL DEVICE VOLUNTARY RECALL" letter dated January 26, 2009 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. Customers were instructed to examine their inventory, remove and quarantine all affected devices. A Recall Effectiveness Check Form was attached for customers to complete and return via fax to 1-866-325-4760. Contact the firm at (888) 888-3433 ext. 5519 for questions regarding this recall.

Device

Device Recall STRYKERArthroscopic Burr
  • Modèle / numéro de série
    Lot numbers: 198025 and 198025.
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, ND, NH, NV, NY, OH, OK, OR, PA, RI, SD, TN, TX, UT, VA, WA, WI, and WY, and the country of Canada.
  • Description du dispositif
    ***CAT 375-941-000***STRYKER***Arthroscopic Bur***4.0mm BARREL BUR***Hollow 6 Flute***RED***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lakeland, FL*** Lot number: 198025***Expiration Date: 11/2011. || ***CAT 375-951-000***STRYKER***Arthroscopic Bur***5.5mm BARREL BUR Hollow 6 Flute***TAN***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lakeland, FL*** Lot number: 199469***Expiration Date: 12/2011. || Reprocessed arthroscopic shavers are indicated for use in orthopedic surgical procedures of the joints, jaw or sinuses where cutting and removal of soft and hard tissue or bone is needed in patients requiring orthopedic surgery.
  • Manufacturer
    Ascent Healthcare Solutions

Manufacturer

Ascent Healthcare Solutions
  • Adresse du fabricant
    Ascent Healthcare Solutions, 10232 S 51st St, Phoenix AZ 85044-5205
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    USFDA