Events

Rappel de Device Recall Juggerknot Soft Anchors

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 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
    59366
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-3109-2011
  • Date de mise en oeuvre de l'événement
    2011-07-21
  • Date de publication de l'événement
    2011-08-31
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-04-26
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102419
  • 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 device packaging was punctured by the device, resulting in loss of implant sterility.
  • Action
    Biomet Sports Medicine notified distributor accounts by telephone on July 08, 2011 with instructions to quarantine all lots of the recalled product. Urgent Medical Device Recall Notice letters dated July 21, 2011 were sent to all affected customers. The letter identified the recalled product, problem, and actions to be taken. The customers were instructed to immediately locate and discontinue use of the recalled product. The distributors are advised to communicate this notice to their customers if the recalled products were further distributed. The letter also states that distributors are responsible for the return of the recalled product. Customers were asked to complete a response form and fax to 574-372-1683, within 3 business days. Customers were instructed to provide phone confirmation at 800-348-9500, extension 3755 or 3756, when the recall notice is received. Further questions should be directed to 574-371-3755 or 574-371-3756, Monday through Friday, 8 AM to 5 PM.

Device

Device Recall Juggerknot Soft Anchors
  • Modèle / numéro de série
    Lot #: M050020, Ml02470, M205970, M206170, M335840, M451670, M554290, M592790, M906510, M050030, M102480, M205980, M206180, M335860, M451680, M554300, M596210, M906540, M050040, M102490, M205990, M206200, M335870, M451690, M554310, M666350, M906550, M050050, M102500, M206000, M213400, M336170, M451700, M555140, M666360, M974690, M050060, M102510, M206010, M213410, M350540, M475050, M571420, M725330, M974720, M050070, M102520, M206030, M213420, M350550, M479960, M571560, M725340, M050080, M102530, M206060, M248050, M350560, M506760, M571570, M727850, M051940, M102540, M206070, M248060, M350570, M513940, M571580, M762160, M051950, M185150, M206080, M248070, M351000, M537410, M571600, M802400, M051960, M185160, M206090, M248080, M354670, M554260, M571730, M802410, M051970, M205940, M206140, M248090, M451650, M554270, M571760, M802420, M072920, M205960, M206150, M248100, M451660, M554280, M571800, and M860160
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of: Columbia, Europe and Korea.
  • Description du dispositif
    REF 91200, Juggerknot system, Soft Anchors, -Two implants size 1, Biomet Sports Medicine, STERILE. || Product Usage: The JuggerKnot Soft Anchors include various size ranges, each consisting of a coreless sleeve and suture(s) assembled on an inserter instrument. The system includes instrumentation allowing for proper preparation and placement of the soft tissue fixation device.
  • Manufacturer
    Biomet, Inc.

Manufacturer

Biomet, Inc.
  • Adresse du fabricant
    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