Events

Rappel de Device Recall MANI Needle and Suture Pack PGA Absorbable

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 Mani, Inc. - Kiyohara Facility.

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
    60225
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0654-2012
  • Date de mise en oeuvre de l'événement
    2011-07-20
  • Date de publication de l'événement
    2012-01-11
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-04-03
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106000
  • 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
    Suture, absorbable, synthetic, polyglycolic acid - Product Code GAM
  • Cause
    Surgical sutures may be weak and may not function as intended during surgical procedures.
  • Action
    The manufacturer notified consignees by phone, via fax with a letter, and e-mail on 07/20/11. The letter asked customers to check their inventory for any of the affected product, and if they had any product remaining to place the amount in the list "Returned." If there was no product left, then the amount used should be placed in the list "Used." Customers needed to complete and sign the document, being sure to send it and any remaining product to the address provided. Credit would be issued once goods were received. If customers have questions, they should contact the firm.

Device

Device Recall MANI Needle and Suture Pack PGA Absorbable
  • Modèle / numéro de série
    Z108002400
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution -- PA and FL.
  • Description du dispositif
    MANI Needle and Suture Pack, 5-0 PGA Absorbable, Model 3391, 45 cm suture and needle, packaged in individual aluminum pack, within tyvek packaging, 12 packages per box, and labeled in part ***Mani, Inc 8-3 Kiyohara Industrial Park Utsunomiya, Tochigi, Japan*** || For use in short term soft tissue approximation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissue.
  • Manufacturer
    Mani, Inc. - Kiyohara Facility

Manufacturer

Mani, Inc. - Kiyohara Facility
  • Adresse du fabricant
    Mani, Inc. - Kiyohara Facility, 8-3 Kiyohara Industrial Park, Utsunomiya-shi, Tochigi-ken Japan
  • Société-mère du fabricant (2017)
    Mani Inc.
  • Source
    USFDA