Events

Rappel de Zimmer™ Orthopaedic Surgical Products, Disposable Cuff, 42in (107cm), Single Port, Single Bladder Sterile, Zimmer, Dover, OH USA. The cuff is a sterile, single use product equipped with an integral fill line. The product is packed 10 cuffs per unit.

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 Zimmer Orthopaedic Surgical Products.

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
    30476
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0388-05
  • Date de mise en oeuvre de l'événement
    2004-10-27
  • Date de publication de l'événement
    2005-01-12
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2005-12-20
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35967
  • 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
    Tourniquet, Pneumatic - Product Code KCY
  • Cause
    The port/tube bond in the affected cuffs may separate during surgery causing the pressure in the cuff to release.
  • Action
    Consignees were first notified via certified mail on 10/27/2004. A follow up letter with 2 addtional lots were sent 11/11/2004.

Device

Zimmer™ Orthopaedic Surgical Products, Disposable Cuff, 42in (107cm), Single Port, Single Bladder...
  • Modèle / numéro de série
    Cat #60-7075-007-00, Lot #60171355. On 02/11/2005 the firm expanded the recall to include all cuffs including the following codes:Cat #60-7075-006-00, Lot #60154126, Single Port Cuff Cat #60-7075-056-00, Lot #60135939, Single Port Cuff, Cat #60-7075-003-00, Lot #60154124, Single Port Cuff, Cat #60-7075-003-00, Lot #60154124, Single Port Cuff, Cat #60-7075-004-00, Lot #60144536, Single Port Cuff, Cat #60-7075-007-00, Lot #60156860, Single Port Cuff, Cat #60-7075-052-00, Lot #60121031, Single Port Cuff, Cat #60-7075-001-00, Lot #60132141, Single Port Cuff, Cat #60-7075-003-00, Lot #60175349, Single Port Cuff, Cat #60-7075-006-00, Lot #60168614, Single Port Cuff, Cat #60-7075-003-00, Lot #60180950, Single Port Cuff, Cat #60-7075-006-00, Lot #60180452, Single Port Cuff, Cat #60-7075-054-00, Lot #60129625, Single Port Cuff, Cat #60-7075-004-00, Lot #60162833, Single Port Cuff, Cat #60-7075-007-00, Lot #60184637, Single Port Cuff, Cat #60-7075-006-00, Lot #60191899, Single Port Cuff, Cat #60-7075-053-00, Lot #60155642, Single Port Cuff, Cat #60-7075-005-00, Lot #60173812, Single Port Cuff, Cat #60-7075-001-00, Lot #60176467, Single Port Cuff, Cat #60-7070-003-00, Lot #60191898, Single Port Cuff, Cat #60-7075-003-00, Lot #60205584, Single Port Cuff, Cat #60-7075-003-00, Lot #60210874, Single Port Cuff, Cat #60-7075-006-00, Lot #60202395, Single Port Cuff, Cat #60-7075-056-00, Lot #60172186, Single Port Cuff, Cat #60-7075-053-00, Lot #60162834, Single Port Cuff, Cat #60-7075-054-00, Lot #60189989, Single Port Cuff, and Cat #60-7075-002-00, Lot #60180458, Single Port Cuff.
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide, Australia, Demark, Germany
  • Description du dispositif
    Zimmer™ Orthopaedic Surgical Products, Disposable Cuff, 42in (107cm), Single Port, Single Bladder Sterile, Zimmer, Dover, OH USA. The cuff is a sterile, single use product equipped with an integral fill line. The product is packed 10 cuffs per unit.
  • Manufacturer
    Zimmer Orthopaedic Surgical Products

Manufacturer

Zimmer Orthopaedic Surgical Products
  • Adresse du fabricant
    Zimmer Orthopaedic Surgical Products, 2021 Old Mountain Rd, Statesville NC 28625-1630
  • Source
    USFDA