Events

Recall of Device Recall GAP ENDOEXO MEDULLARY SYSTEM

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Pega Medical Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    70630
  • Event Risk Class
    Class 2
  • Event Number
    Z-1362-2015
  • Event Initiated Date
    2015-02-20
  • Event Date Posted
    2015-04-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-04-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134174
  • Notes / Alerts
    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.
  • Extra notes in the data
    Rod, fixation, intramedullary and accessories - Product Code HSB
  • Reason
    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
  • Model / Serial
    Lot numbers: 110913-001; 110913-002; 110913-004; 110913-005;
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Nationwide Distribution in the states of: California, Florida, New York, and Puerto Rico (US).
  • Product Description
    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.
  • Manufacturer Address
    Pega Medical Inc., 1111 Autoroute Chomedy, Laval Canada
  • Manufacturer Parent Company (2017)
    Pega Medical Inc.
  • Source
    USFDA