Events

Rappel de Device Recall Synovis PetriStrips Dry with Veritas Collagen Matrix (PSDV)

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 Synovis Surgical Inovation Div. of.

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
    37671
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0960-2007
  • Date de mise en oeuvre de l'événement
    2007-03-16
  • Date de publication de l'événement
    2007-06-15
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2008-02-24
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51278
  • 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
    Surgical Mesh - Product Code FTM
  • Cause
    Package integrity/sterility compromised: the foil pouch in the peri-strips dry with veritas collagen matrix circular staple line reinforcement has a potential for minute defects which may compromise the sterility of the outside of the tray in which the device is packaged.
  • Action
    Recall notification letters were sent to hospitals via Federal Express on 03/16/2007. This letter describes the product being recalled and problem. It requests consignees to complete and fax back the product return form. EXPANDED Another recall letter dated 04/23/2007 was sent to inform customers of 17 aditional lot numbers being recalled. A third recall letter dated 05/05/2007 was set to hospitals to inform them of one additional Lot/Serial number that was affected. This letter also requests a product return form be completed and faxed to Synovis Surgical Innovations.

Device

Device Recall Synovis PetriStrips Dry with Veritas Collagen Matrix (PSDV)
  • Modèle / numéro de série
    5713042-221741, 5713423-227242, 5717696-316474, 5717892-318414, 5718084-321564, 5718811-335330, 5718931-337921, 5719156-342542, 5717892-408336, 5718084-408339, 5719536-348390, 5721731-391016, 5721732-391017, 5721988-395784, 5722089-397032, 5725033-478976, 5725482-487062, 5725665-491224, 5725782-495452, 5726120-498547, 5727333-525321, 5721988-540345, 5727334-525322. EXPANDED LOT/SERIAL #'s: 5728409-544891, 5729325-562207, 5727334-560764.
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide including states of AZ, CA, CT, FL, IA, IL, IN, KY, MA, MI, MN, MO, NJ, NY, OH, OK, PA, TN, TX, VA, and WI
  • Description du dispositif
    Synovis Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement,( PSD 21-E-V), 21mm, Ethicon Circular stapler. Each package contains the following components: Cartridge and anvil assemblies, Cartridge cone, PSD Gel, & C-clip.
  • Manufacturer
    Synovis Surgical Inovation Div. of

Manufacturer

Synovis Surgical Inovation Div. of
  • Adresse du fabricant
    Synovis Surgical Inovation Div. of, 2575 University Ave W, Saint Paul MN 55114-1073
  • Source
    USFDA