Events

Rappel de Device Recall Ziptight Ankle Syndesmosis Fixation

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
    79973
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1915-2018
  • Date de mise en oeuvre de l'événement
    2017-08-22
  • 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=164064
  • 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
    Fastener, fixation, nondegradable, soft tissue - Product Code MBI
  • Cause
    The product was packaged without the tip protectors.
  • Action
    August 22, 2017 letter to Risk Managers and Surgeons includes the following instructions: Risk Manager Responsibilities: 1. Review this notification and ensure affected personnel are aware of the contents. 2. Assist your Zimmer Biomet sales representative quarantine all affected product. 3. Your Zimmer Biomet sales representative will remove the affected product from your facility. 4. Complete Attachment 1  Certificate of Acknowledgement. a. Return a digital copy to corporatequality.postmarket@zimmerbiomet.com. b. Retain a copy of the Acknowledgement Form with your field action records in the event of a compliance audit of your facilities documentation. 5. If after reviewing this notice you have further questions or concerns please call the customer call center at 1-574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of the call center operating hours will receive a prompt to record a voicemail or be transferred to an on-call representative in the case of an emergency. Alternatively, your questions may be sent by email to corporatequality.postmarket@zimmerbiomet.com. Surgeon Responsibilities: 1. Review this notification for awareness of the contents. 2. There are no specific patient monitoring instructions related to this field action that are recommended beyond your existing follow up schedule. 3. Complete Attachment 1  Certificate of Acknowledgement. a. Return a digital copy to corporatequality.postmarket@zimmerbiomet.com. b. Retain a copy of the Acknowledgement Form with your field action records in the event of a compliance audit of your documentation. 4. If after reviewing the notice you have further questions or concerns please call the customer call center at 1-877-946-2761 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of the call center operating hours will receive a prompt to record a voicemail or be transferred to an on-call representative in the case of an emergenc

Device

Device Recall Ziptight Ankle Syndesmosis Fixation
  • Modèle / numéro de série
    Lot #: 058860, 058880, 058890, 058910, 116030, 169780, 169790, 213450, 213480, 374420, 392530, 476670, 503830, 614910, 670640, 728190, 984070, 984080;  UDI #:  (01)00880304476103(17)220523(10)058860,  (01)00880304476103(17)220608(10)058880,  (01)00880304476103(17)220608(10)058890,  (01)00880304476103(17)220608(10)058910,  (01)00880304476103(17)220519(10)116030,  (01)00880304476103(17)220609(10)169780,  (01)00880304476103(17)220608(10)169790,  (01)00880304476103(17)220609(10)213450,  (01)00880304476103(17)220607(10)213480,  (01)00880304476103(17)220319(10)374420,  (01)00880304476103(17)220610(10)392530,  (01)00880304476103(17)220607(10)476670,  (01)00880304476103(17)220608(10)503830,  (01)00880304476103(17)220421(10)614910,  (01)00880304476103(17)220621(10)670640,  (01)00880304476103(17)220606(10)728190,  (01)00880304476103(17)220512(10)984070,  (01)00880304476103(17)220607(10)984080
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide distribution. US nationwide, Argentina, Australia, Canada, Costa Rica, Japan, and Netherlands.
  • Description du dispositif
    Ziptight Ankle Syndesmosis Fixation - Ti, Item # 904759 orthopedic fixation device
  • Manufacturer
    Zimmer Biomet, Inc.

Manufacturer

Zimmer Biomet, Inc.
  • Adresse du fabricant
    Zimmer Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582-6989
  • 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