Events

Rappel de Device Recall GAP ENDOEXO MEDULLARY 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 Pega Medical 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
    70630
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1362-2015
  • Date de mise en oeuvre de l'événement
    2015-02-20
  • Date de publication de l'événement
    2015-04-02
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-04-30
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134174
  • 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
    Rod, fixation, intramedullary and accessories - Product Code HSB
  • Cause
    Failures of the 4.8mm of the gap endo-exo medullary system have been identified at the level of the distal cortical screw holes. failures mainly occurred in patients with tibial pseudoarthrosis (cpt) or osteogenesis imperfecta (oi). higher failure rates have been detected in tibias with distal fractures that are close to the distal locking holes.
  • Action
    Pega Medical sent the Urgent Field Safety Notice-Recall/Advisory Notice letter, dated 2015/02/20, to US consignees (surgeons) via email. The following actions were advised: 1. It is recommended to monitor patients as considered necessary in order to ensure that weight bearing does not take place until full consolidation of the fracture/osteotomy is completed and that weight bearing is applied progressively. 2. Report to the distributor or Pega Medical any adverse event observed. In cases where the consolidation has occurred, normal patient follow up can be continued with no serious consequences to the patient. In cases where consolidation has not been achieved after six weeks, replacement of the nail might be necessary. 3. All surgeons receiving this notice must acknowledge reception by a written confirmation sent to the distributor or to the contact reference person indicated below. US consignees with questions can call Pega Medical at 450-688-5144 ext. 242, or send fax to 450-688-1977, or send email to egarcia@pegamedical.com.

Device

Device Recall GAP ENDOEXO MEDULLARY SYSTEM
  • Modèle / numéro de série
    Lot numbers: 110913-001; 110913-002; 110913-004; 110913-005;
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    US Nationwide Distribution in the states of: California, Florida, New York, and Puerto Rico (US).
  • Description du dispositif
    GAP Nail 4.8mm (diameter size) of the GAP ENDO-EXO MEDULLARY SYSTEM. Catalog number GAP-N48-16; GAP-N48-18; GAP-N48-26; GAP-N48-28. || Product Usage: || The GAP Endo-Exo Medullary System is used for the treatment of fractures or correction of deformities in the femur, tibia and humerus of pediatric patients, who have reached skeletal maturity. The GAP Nail is an intramedullary nail. It is the main component of the GAP Endo-Exo Medullary System. The rest of the components of the system are screws, plates and caps that are assembled to the nail during the surgical procedure. The GAP Endo-Exo Medullary System is indicated as a temporary implant to assure alignment, stabilization and fixation of: long bones that have been surgically prepared (osteotomy) for correction of deformities or fractures caused by trauma or disease. The GAP System is used for pediatric patients (child and adolescent) ages 2 to 21. It can be used to correct the following conditions: -Diaphyseal fracture of the femur, tibia and humerus -Fractures of the femoral neck -Subtrochanteric, intertrochanteric and combination fractures -Correction of deformities (OI, Coxa vara, Coxa valga) -Nonunions and malunions
  • Manufacturer
    Pega Medical Inc.

Manufacturer

Pega Medical Inc.
  • Adresse du fabricant
    Pega Medical Inc., 1111 Autoroute Chomedy, Laval Canada
  • Société-mère du fabricant (2017)
    Pega Medical Inc.
  • Source
    USFDA