Events

Rappel de Zimmer Natural Nail CM Long

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 Gmbh.

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
    72123
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0119-2016
  • Date de mise en oeuvre de l'événement
    2015-09-03
  • Date de publication de l'événement
    2015-10-14
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-03-15
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139914
  • 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
    Rod, fixation, intramedullary and accessories - Product Code HSB
  • Cause
    In about 5% of tested samples, the outer tray was found to be compromised. risks: a damaged outer tray detected during surgery may cause a delay in surgery to obtain another implant. if a compromised packaging is not detected prior or during a surgery by the user, it may lead to periprosthetic infection. this may result in revision or multi-stage revision to treat the infection.
  • Action
    On 9/3/2015, URGENT MEDICAL DEVICE RECALL notifications were sent via courier to the affected distributors and Hospital Risk Managers with instructions for locating and inspecting the affected devices and contacting Zimmer if damage is observed. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. If after reviewing this notification you have questions concerning this notification, please call 1-877-946-2761.

Device

Zimmer Natural Nail CM Long
  • Modèle / numéro de série
    All Lots. Item number and name: 47-2493-481-10 ZNN CMN Nail 10mmX48cm 125 L 47-2493-442-10 ZNN CMN Nail 10mmX44cm 130 R 47-2493-480-10 ZNN CMN Nail 10mmX48cm 125 R 47-2493-445-10 ZNN CMN Nail 10mmX44cm 135 L 47-2493-483-10 ZNN CMN Nail 10mmX48cm 130 L 47-2493-444-10 ZNN CMN Nail 10mmX44cm 135 R 47-2493-482-10 ZNN CMN Nail 10mmX48cm 130 R 47-2493-441-11 ZNN CMN Nail 11.5mmX44cm 125 L 47-2493-485-10 ZNN CMN Nail 10mmX48cm 135 L 47-2493-440-11 ZNN CMN Nail 11.5mmX44cm 125 R 47-2493-484-10 ZNN CMN Nail 10mmX48cm 135 R 47-2493-443-11 ZNN CMN Nail 11.5mmX44cm 130 L 47-2493-481-11 ZNN CMN Nail 11.5mmX48cm 125 L 47-2493-442-11 ZNN CMN Nail 11.5mmX44cm 130 R 47-2493-480-11 ZNN CMN Nail 11.5mmX48cm 125 R 47-2493-445-11 ZNN CMN Nail 11.5mmX44cm 135 L 47-2493-483-11 ZNN CMN Nail 11.5mmX48cm 130 L 47-2493-444-11 ZNN CMN Nail 11.5mmX44cm 135 R 47-2493-482-11 ZNN CMN Nail 11.5mmX48cm 130 R 47-2493-441-13 ZNN CMN Nail 13mmX44cm 125 L 47-2493-485-11 ZNN CMN Nail 11.5mmX48cm 135 L 47-2493-440-13 ZNN CMN Nail 13mmX44cm 125 R 47-2493-484-11 ZNN CMN Nail 11.5mmX48cm 135 R 47-2493-443-13 ZNN CMN Nail 13mmX44cm 130 L 47-2493-481-13 ZNN CMN Nail 13mmX48cm 125 L 47-2493-442-13 ZNN CMN Nail 13mmX44cm 130 R 47-2493-480-13 ZNN CMN Nail 13mmX48cm 125 R 47-2493-445-13 ZNN CMN Nail 13mmX44cm 135 L 47-2493-483-13 ZNN CMN Nail 13mmX48cm 130 L 47-2493-444-13 ZNN CMN Nail 13mmX44cm 135 R 47-2493-482-13 ZNN CMN Nail 13mmX48cm 130 R 47-2493-421-10 ZNN CMN Nail 10mmX42cm 125 L 47-2493-485-13 ZNN CMN Nail 13mmX48cm 135 L 47-2493-420-10 ZNN CMN Nail 10mmX42cm 125 R 47-2493-484-13 ZNN CMN Nail 13mmX48cm 135 R 47-2493-423-10 ZNN CMN Nail 10mmX42cm 130 L 47-2493-463-13 ZNN CMN Nail 13mmX46cm 130 L 47-2493-422-10 ZNN CMN Nail 10mmX42cm 130 R 47-2493-461-10 ZNN CMN Nail 10mmX46cm 125 L 47-2493-425-10 ZNN CMN Nail 10mmX42cm 135 L 47-2493-460-10 ZNN CMN Nail 10mmX46cm 125 R 47-2493-424-10 ZNN CMN Nail 10mmX42cm 135 R 47-2493-463-10 ZNN CMN Nail 10mmX46cm 130 L 47-2493-421-11 ZNN CMN Nail 11.5mmX42cm 125 L 47-2493-462-10 ZNN CMN Nail 10mmX46cm 130 R 47-2493-420-11 ZNN CMN Nail 11.5mmX42cm 125 R 47-2493-465-10 ZNN CMN Nail 10mmX46cm 135 L 47-2493-423-11 ZNN CMN Nail 11.5mmX42cm 130 L 47-2493-464-10 ZNN CMN Nail 10mmX46cm 135 R 47-2493-422-11 ZNN CMN Nail 11.5mmX42cm 130 R 47-2493-461-11 ZNN CMN Nail 11.5mmX46cm 125 L 47-2493-425-11 ZNN CMN Nail 11.5mmX42cm 135 L 47-2493-460-11 ZNN CMN Nail 11.5mmX46cm 125 R 47-2493-424-11 ZNN CMN Nail 11.5mmX42cm 135 R 47-2493-463-11 ZNN CMN Nail 11.5mmX46cm 130 L 47-2493-421-13 ZNN CMN Nail 13mmX42cm 125 L 47-2493-462-11 ZNN CMN Nail 11.5mmX46cm 130 R 47-2493-420-13 ZNN CMN Nail 13mmX42cm 125 R 47-2493-465-11 ZNN CMN Nail 11.5mmX46cm 135 L 47-2493-423-13 ZNN CMN Nail 13mmX42cm 130 L 47-2493-464-11 ZNN CMN Nail 11.5mmX46cm 135 R 47-2493-422-13 ZNN CMN Nail 13mmX42cm 130 R 47-2493-461-13 ZNN CMN Nail 13mmX46cm 125 L 47-2493-425-13 ZNN CMN Nail 13mmX42cm 135 L 47-2493-460-13 ZNN CMN Nail 13mmX46cm 125 R 47-2493-424-13 ZNN CMN Nail 13mmX42cm 135 R 47-2493-462-13 ZNN CMN Nail 13mmX46cm 130 R 47-2493-401-10 ZNN CMN Nail 10mmX40cm 125 L 47-2493-465-13 ZNN CMN Nail 13mmX46cm 135 L 47-2493-400-10 ZNN CMN Nail 10mmX40cm 125 R 47-2493-464-13 ZNN CMN Nail 13mmX46cm 135 R 47-2493-403-10 ZNN CMN Nail 10mmX40cm 130 L 47-2493-441-10 ZNN CMN Nail 10mmX44cm 125 L 47-2493-402-10 ZNN CMN Nail 10mmX40cm 130 R 47-2493-440-10 ZNN CMN Nail 10mmX44cm 125 R 47-2493-405-10 ZNN CMN Nail 10mmX40cm 135 L 47-2493-443-10 ZNN CMN Nail 10mmX44cm 130 L 47-2493-404-10 ZNN CMN Nail 10mmX40cm 135 R 47-2493-401-11 ZNN CMN Nail 11.5mmX40cm 125 L 47-2493-340-10 ZNN CMN Nail 10mmX34cm 125 R 47-2493-400-11 ZNN CMN Nail 11.5mmX40cm 125 R 47-2493-343-10 ZNN CMN Nail 10mmX34cm 130 L 47-2493-403-11 ZNN CMN Nail 11.5mmX40cm 130 L 47-2493-342-10 ZNN CMN Nail 10mmX34cm 130 R 47-2493-402-11 ZNN CMN Nail 11.5mmX40cm 130 R 47-2493-341-11 ZNN CMN Nail 11.5mmX34cm 125 L 47-2493-405-11 ZNN CMN Nail 11.5mmX40cm 135 L 47-2493-340-11 ZNN CMN Nail 11.5mmX34cm 125 R 47-2493-404-11 ZNN CMN Nail 11.5mmX40cm 135 R 47-2493-343-11 ZNN CMN Nail 11.5mmX34cm 130 L 47-2493-401-13 ZNN CMN Nail 13mmX40cm 125 L 47-2493-342-11 ZNN CMN Nail 11.5mmX34cm 130 R 47-2493-400-13 ZNN CMN Nail 13mmX40cm 125 R 47-2493-341-13 ZNN CMN Nail 13mmX34cm 125 L 47-2493-403-13 ZNN CMN Nail 13mmX40cm 130 L 47-2493-340-13 ZNN CMN Nail 13mmX34cm 125 R 47-2493-402-13 ZNN CMN Nail 13mmX40cm 130 R 47-2493-343-13 ZNN CMN Nail 13mmX34cm 130 L 47-2493-405-13 ZNN CMN Nail 13mmX40cm 135 L 47-2493-342-13 ZNN CMN Nail 13mmX34cm 130 R 47-2493-404-13 ZNN CMN Nail 13mmX40cm 135 R 47-2493-321-10 ZNN CMN Nail 10mmX32cm 125 L 47-2493-381-10 ZNN CMN Nail 10mmX38cm 125 L 47-2493-320-10 ZNN CMN Nail 10mmX32cm 125 R 47-2493-380-10 ZNN CMN Nail 10mmX38cm 125 R 47-2493-323-10 ZNN CMN Nail 10mmX32cm 130 L 47-2493-383-10 ZNN CMN Nail 10mmX38cm 130 L 47-2493-322-10 ZNN CMN Nail 10mmX32cm 130 R 47-2493-382-10 ZNN CMN Nail 10mmX38cm 130 R 47-2493-321-11 ZNN CMN Nail 11.5mmX32cm 125 L 47-2493-381-11 ZNN CMN Nail 11.5mmX38cm 125 L 47-2493-320-11 ZNN CMN Nail 11.5mmX32cm 125 R 47-2493-380-11 ZNN CMN Nail 11.5mmX38cm 125 R 47-2493-323-11 ZNN CMN Nail 11.5mmX32cm 130 L 47-2493-383-11 ZNN CMN Nail 11.5mmX38cm 130 L 47-2493-322-11 ZNN CMN Nail 11.5mmX32cm 130 R 47-2493-382-11 ZNN CMN Nail 11.5mmX38cm 130 R 47-2493-321-13 ZNN CMN Nail 13mmX32cm 125 L 47-2493-381-13 ZNN CMN Nail 13mmX38cm 125 L 47-2493-320-13 ZNN CMN Nail 13mmX32cm 125 R 47-2493-380-13 ZNN CMN Nail 13mmX38cm 125 R 47-2493-323-13 ZNN CMN Nail 13mmX32cm 130 L 47-2493-383-13 ZNN CMN Nail 13mmX38cm 130 L 47-2493-322-13 ZNN CMN Nail 13mmX32cm 130 R 47-2493-382-13 ZNN CMN Nail 13mmX38cm 130 R 47-2493-301-10 ZNN CMN Nail 10mmX30cm 125 L 47-2493-361-10 ZNN CMN Nail 10mmX36cm 125 L 47-2493-300-10 ZNN CMN Nail 10mmX30cm 125 R 47-2493-360-10 ZNN CMN Nail 10mmX36cm 125 R 47-2493-303-10 ZNN CMN Nail 10mmX30cm 130 L 47-2493-363-10 ZNN CMN Nail 10mmX36cm 130 L 47-2493-302-10 ZNN CMN Nail 10mmX30cm 130 R 47-2493-362-10 ZNN CMN Nail 10mmX36cm 130 R 47-2493-301-11 ZNN CMN Nail 11.5mmX30cm 125 L 47-2493-361-11 ZNN CMN Nail 11.5mmX36cm 125 L 47-2493-300-11 ZNN CMN Nail 11.5mmX30cm 125 R 47-2493-360-11 ZNN CMN Nail 11.5mmX36cm 125 R 47-2493-303-11 ZNN CMN Nail 11.5mmX30cm 130 L 47-2493-363-11 ZNN CMN Nail 11.5mmX36cm 130 L 47-2493-302-11 ZNN CMN Nail 11.5mmX30cm 130 R 47-2493-362-11 ZNN CMN Nail 11.5mmX36cm 130 R 47-2493-301-13 ZNN CMN Nail 13mmX30cm 125 L 47-2493-361-13 ZNN CMN Nail 13mmX36cm 125 L 47-2493-300-13 ZNN CMN Nail 13mmX30cm 125 R 47-2493-360-13 ZNN CMN Nail 13mmX36cm 125 R 47-2493-303-13 ZNN CMN Nail 13mmX30cm 130 L 47-2493-363-13 ZNN CMN Nail 13mmX36cm 130 L 47-2493-302-13 ZNN CMN Nail 13mmX30cm 130 R 47-2493-362-13 ZNN CMN Nail 13mmX36cm 130 R 47-2493-305-10 ZNN CMN Nail 10mmX30cm 135 L 47-2493-341-10 ZNN CMN Nail 10mmX34cm 125 L 47-2493-305-11 ZNN CMN Nail 11.5mmX30cm 135 L 47-2493-325-10 ZNN CMN Nail 10mmX32cm 135 L 47-2493-305-13 ZNN CMN Nail 13mmX30cm 135 L 47-2493-325-11 ZNN CMN Nail 11.5mmX32cm 135 L 47-2493-365-13 ZNN CMN Nail 13mmX36cm 135 L 47-2493-325-13 ZNN CMN Nail 13mmX32cm 135 L 47-2493-344-10 ZNN CMN Nail 10mmX34cm 135 R 47-2493-304-10 ZNN CMN Nail 10mmX30cm 135 R 47-2493-344-11 ZNN CMN Nail 11.5mmX34cm 135 R 47-2493-304-11 ZNN CMN Nail 11.5mmX30cm 135 R 47-2493-344-13 ZNN CMN Nail 13mmX34cm 135 R 47-2493-304-13 ZNN CMN Nail 13mmX30cm 135 R 47-2493-364-10 ZNN CMN Nail 10mmX36cm 135 R 47-2493-324-10 ZNN CMN Nail 10mmX32cm 135 R 47-2493-364-11 ZNN CMN Nail 11.5mmX36cm 135 R 47-2493-324-11 ZNN CMN Nail 11.5mmX32cm 135 R 47-2493-364-13 ZNN CMN Nail 13mmX36cm 135 R 47-2493-324-13 ZNN CMN Nail 13mmX32cm 135 R 47-2493-385-10 ZNN CMN Nail 10mmX38cm 135 L 47-2493-345-10 ZNN CMN Nail 10mmX34cm 135 L 47-2493-385-11 ZNN CMN Nail 11.5mmX38cm 135 L 47-2493-345-11 ZNN CMN Nail 11.5mmX34cm 135 L 47-2493-385-13 ZNN CMN Nail 13mmX38cm 135 L 47-2493-345-13 ZNN CMN Nail 13mmX34cm 135 L 47-2493-384-10 ZNN CMN Nail 10mmX38cm 135 R 47-2493-365-10 ZNN CMN Nail 10mmX36cm 135 L 47-2493-384-11 ZNN CMN Nail 11.5mmX38cm 135 R 47-2493-365-11 ZNN CMN Nail 11.5mmX36cm 135 L 47-2493-384-13 ZNN CMN Nail 13mmX38cm 135 R
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    US Nationwide distribution.
  • Description du dispositif
    Zimmer Natural Nail CM Long. Intramedullary Fixation Rod. || The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone.
  • Manufacturer
    Zimmer Gmbh

Manufacturer

Zimmer Gmbh
  • Adresse du fabricant
    Zimmer Gmbh, Sulzer Allee 8, Winterthur Switzerland
  • Société-mère du fabricant (2017)
    Zimmer Biomet Holdings
  • Commentaire du fabricant
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    USFDA