Events

Rappel de Device Recall ECT Internal Fracture Fixation Drill

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 Biomet, 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
    77417
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-3170-2017
  • Date de mise en oeuvre de l'événement
    2017-05-22
  • Date de publication de l'événement
    2017-09-22
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=158396
  • 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
    Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment - Product Code HWE
  • Cause
    A raw material anomaly was discovered during inspection at zimmer biomet, and an investigation by the supplier determined that 4 lots of raw material could have similar anomalies. the anomaly has the potential to be on or below the surface and can increase the risk of instrument fracture. accordingly, all products manufactured with the affected raw material are being removed from the field.
  • Action
    On 5/22/2017, Zimmer Biomet distributed Urgent Medical Device Recall notices to their customers and distributors. On 12/19/2017, Zimmer Biomet sent Urgent Medical Device Recall notices to their customers due to a recall expansion involving one (1) lot for product # 20. Customers are advised to review the notice and ensure that affected personnel are aware of the contents. All stock should be inspected and product quarantined. A Zimmer Biomet sales representative will remove the affected product from your facility. Customers should complete and return the Certificate of Acknowledgement via email to: corporatequality.postmarket@zimmerbiomet.com and retain the copy for your files. Customers with questions may call the customer call center at 574-371-3071, Monday through Friday 8 am - 5 pm, EST. *For Distributors Your Responsibilities include the following: 1. Review this notification and ensure affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 3. Complete the Certification of Acknowledgement portion of Attachment 1  Inventory Return Certification Form. a. Return a digital copy to corporatequality.postmarket@zimmerbiomet.com within three (3) days. 4. Immediately return all affected product from your distributorship and affected hospitals within your territory along with a completed Attachment 1  Inventory Return Certification Form to Zimmer Biomet. a. For each return, send a copy of the completed acknowledgement form via email to: corporatequality.postmarket@zimmerbiomet.com. b. Include a hardcopy of Attachment 1 with your shipment for immediate processing. c. Include a copy of Attachment 3  Certificate of Sterilization with returned instruments. d. Mark the outside of the returns box(es) clearly with FIELD ACTION. 5. Note that any hospitals that received direct shipments of this product from Zimmer Biomet will be sent a copy of the Risk Manager Field Action Notice direc

Device

Device Recall ECT Internal Fracture Fixation Drill
  • Modèle / numéro de série
    Lot Numbers: 63556702, 63593924, 63593925, 63616888, 63340538, 63340539, 63358202, 63358203, 63372868, 63398777, 63478700,  63479007, 63479008, 63479009, 63517947 & 63524439.
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.
  • Description du dispositif
    ECT Internal Fracture Fixation Drill 3.2 mm Diameter (.126 Inch), Item Number/EDI 00231803200, Nonsterile
  • Manufacturer
    Zimmer Biomet, Inc.

Manufacturer

Zimmer Biomet, Inc.
  • Adresse du fabricant
    Zimmer Biomet, Inc., 1800 W Center St, Warsaw IN 46580-2304
  • 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