Events

Rappel de 1100 Series Aluminum Retractors

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 Lone Star Medical Products, 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
    36592
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0214-2007
  • Date de mise en oeuvre de l'événement
    2004-10-06
  • Date de publication de l'événement
    2006-11-28
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2006-12-22
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49003
  • 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
    Retractors - Product Code GAD
  • Cause
    Ni-cr plated 1100 series retractors with a chromium finish were replaced by retractors with a hard-anodized finish after complaints of peeling were received.
  • Action
    For domestic customers, the firm sent product replacement letters to customers (as listed on the firm's invoices), and hospital operating room personnel on October 6, 2004. On November 8, 2004, a faxed letter was sent to the Purchasing/Materials Management Department of all customers. From November 9 through November 12, 2004, a phone call drive was conducted to contact appropriate individuals for each customer. For international customers, the firm notified distributors and obtained end user details from them. End users were then contacted and communicated with regarding the product replacement. In addition, the firm utilized its Summer and Fall 2004 newsletters to communicate the product replacement information. Customers were encouraged to return NiCr coated products for a hard-anodized coated replacement product.

Device

1100 Series Aluminum Retractors
  • Modèle / numéro de série
    Lot #5868 (Serial numbers: 7558 thru 7565); Lot #5890 (Serial numbers: 5230 thru 5243 and 7548) & Lot #5923 (Serial numbers: 7533, 7536, 7539, 7543 thru 7545, 7548 and 7549).
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    World wide, including USA, Denmark, Germany, Finland, France, Taiwan, Canada, South Korea, New Zealand, Hong Kong, Italy, England, Australia, Saudi Arabia, South Africa and Singapore.
  • Description du dispositif
    Lone Star Medical Products, Inc. 1100 Series Aluminum Retractor Rings, model #1110; manufactured by Lone Star Medical Products, Inc.
  • Manufacturer
    Lone Star Medical Products, Inc

Manufacturer

Lone Star Medical Products, Inc
  • Adresse du fabricant
    Lone Star Medical Products, Inc, 11211 Cash Rd, Stafford TX 77477
  • Source
    USFDA