Events

Rappel de Device Recall Ocular Motility Peg system

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 Integrated Orbital Implants 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
    37139
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0396-2007
  • Date de mise en oeuvre de l'événement
    2006-12-20
  • Date de publication de l'événement
    2007-02-07
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2007-07-12
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49970
  • 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
    ocular implant - Product Code MQU
  • Cause
    The threads on the threaded sleeve were manufactured with left-handed threads, requiring a modification to the surgical technique for proper insertion. failure to properly identify the affected components and apply the modified insertion technique will result in an inability to insert the sleeve into the implant.
  • Action
    All domestic customers were notified by phone call on 12//20/2006 which was followed up with a fax and the letter sent registered mail. Internationally, customers were notified by fax, email and mail. Customers were instructed to check their inventory of the product by lot number and visual inspection. They were instructed to isolate the affected inventory. They were provided with alternate instructions on how to use the product as it is, if needed. They were provided with a reply card to complete and fax back to the company. They were instructed that when replacement product becomes available, they will be contacted to arrange for the exchange of the affected product.

Device

Device Recall Ocular Motility Peg system
  • Modèle / numéro de série
    Lot number: M-50021 Product is not serialized.  Note: Lot code assigned by the contract manufacturing firm.
  • Classification du dispositif
    Ophthalmic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide, including USA, United Arab Emirates, Canada, Mexico, Costa Rica, Taiwan & Romania.
  • Description du dispositif
    Perry-Kolberg Titanium Motility/Support System (Threaded Sleeve and Flat Peg), Model Number 100045 || The threaded sleeve and flat peg are two components of the P-K Titanium Motility/Support System. The threaded sleeve is an externally threaded cylinder and an internal drilled hole designed to receive a peg. It is placed in the Bioeye Hydroxyapatite Implant with the use of the P-K Titanium threaded sleeve wrench after a hole has been prepared in the implant by drilling with a series of hypodermic needles of gradually increasing sizes. After the threaded sleeve is placed in the implant, any of the P-K Pegs can be inserted. || The affected model which is the subject of this recall comes with the flat peg.
  • Manufacturer
    Integrated Orbital Implants Inc

Manufacturer

Integrated Orbital Implants Inc
  • Adresse du fabricant
    Integrated Orbital Implants Inc, 12625 High Bluff Dr Ste 314, San Diego CA 92130-2054
  • Source
    USFDA