Events

Rappel de Synvasive

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 Synvasive Technology 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
    64810
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1115-2013
  • Date de mise en oeuvre de l'événement
    2013-04-02
  • Date de publication de l'événement
    2013-04-15
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-07-15
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117111
  • 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
    Blade, saw, general & plastic surgery, surgical - Product Code GFA
  • Cause
    Various reciprocating and oscillating saw blades were incorrectly labeled. the labeling errors include: (1) the pouch says oscillating saw blade when it actually contains a reciprocating saw blade; (2) the box bar code date does not match the human readable expiration date; and (3) the label incorrectly states use with zimmer/synthes handset and not the zimmer universal power system.
  • Action
    Zimmer sent a Urgent Device Removal letter dated April 2, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers that received affected product from both Synvasive and from Zimmer Surgical will receive two customer letters, as each letter sets out specific item and lot numbers dependent upon distribution entity. Zimmer Distributors will also receive an e-mail notification. All notifications include a response form for both Synvasive and Zimmer distributors as well as customer consignees to account for product disposition (disposal in the field per facilities' sharps protocol). (1) Notifications will be mailed via Fed Ex to Risk Managers and Zimmer Distributors with inventory. (2) Notifications will be emailed to international geographies. (3) Notifications will be emailed all Zimmer Distributors. (4) A second Fed Ex mailing will be sent to domestic non-responding consignees. (5) Effectiveness phone calls will be made to any remaining domestic non-responding consignees. (6) If a customer reports they have further distributed the product, the secondary consignee identified will receive a notification from Zimmer. The scope of the recall is limited to certain confirmed lots which were shipped to the affected consignees. .E-mails, certified mail receipts, and telephone records will be the firm's course of action in monitoring effectiveness checks. All returns will be stored in a separate area away from regular inventory. Final disposition of returned product is yet to be determined. The firm's recall strategy appears to be adequate. For further questions please call (916) 939-3913.

Device

Synvasive
  • Modèle / numéro de série
    Lots Numbers included in Recall: 1X311,01251,16325,15023,15024,1Y224,23326,0X401,26385,1Y174, 17151,0Y280,17150,22028,28114,19071,23372,23346,23504,23505, 25134,25341,2W223,2X105,26001,2W573,2W574,24348,25304, 25333,26068,26165,27015,27016,29392,PD4647
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and countries of: Austria, Australia, Belgium, Czech Republic, Denmark, Finland, France, Germany, Italy, Japan, Netherlands, Norway, Panama, Spain, Sweden, Switzerland, Tunisia, United Kingdom and Yemen.
  • Description du dispositif
    Product is distributed by Zimmer (Warsaw, Indiana)/Synvasive Technology, Inc. (El Dorado Hills, CA) & manufactured under Synvasive Technology, Inc. El Dorado Hills, CA || Reciprocating saw blade: A sterile surgical saw blade used to resect damaged cartilage and/or bond in an orthopaedic reconstructive procedure such as a total knee replacement.
  • Manufacturer
    Synvasive Technology Inc

Manufacturer

Synvasive Technology Inc
  • Adresse du fabricant
    Synvasive Technology Inc, 4925 Robert J Mathews Pkwy, El Dorado Hills CA 95762-5701
  • 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