Events

Retiro De Equipo (Recall) de Device Recall SIGMA HP PFJ Cemented Trochlear Implant

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por DePuy Orthopaedics, Inc..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    79475
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1219-2018
  • Fecha de inicio del evento
    2017-12-21
  • Fecha de publicación del evento
    2018-03-20
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162430
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Prosthesis, knee, femorotibial, semi-constrained, cemented, metal/polymer - Product Code HRY
  • Causa
    The sigma¿ hp pfj cemented trochlear implants, a standalone component of the partial knee system is being recalled based on elevated revision rates observed as part of the company s post market surveillance process.
  • Acción
    Notifications were sent to the firm's consignees with the following instructions. Immediately Inspect Inventory: DISTRIBUTORS & SALES OFFICES: Inspect all inventory to identify any affected devices. 2. Return Affected U.S. Distributor/Sales Office Inventory: If any affected devices are found in a U.S. Distributors/Sales Offices inventory, return to: DePuy Synthes Joint Reconstruction 3. To Expedite the Return Process: Be sure to reference H17-19 on all return paperwork and/or online return forms and on the outside of the box when returning recalled devices. 4. Upon receipt of the affected devices, a credit will be issued using the normal returns process. 5. Identify Consignment Hospitals: Within 5-business days, complete the Distributor / Sales Office Response Card: 5.1. Provide the Medical Facility contact information and indicate the US Distributor/Sales Office has returned all affected devices. MEDICAL PROFESSIONALS: Steps to Take: " Cease using the affected components. " Return Affected Implants: Complete the reconciliation form and return to the sales consultant or fax to 574-371-4939 within five (5) days of this notice. Additional Notifications: o Notify surgeon users at your facility by providing them with a copy of this notice to ensure surgeon users are aware of this device recall. Forward this notice to others in your facility that need to be informed. o If any affected product has been forwarded to another facility, contact that facility immediately to communicate this field action with the facility/facilities. For further questions, please call (574) 372-7136.

Device

Device Recall SIGMA HP PFJ Cemented Trochlear Implant
  • Modelo / Serial
    All lots
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico and to the states of : AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and the District of Columbia., and to the countries of : Australia, Austria, Belgium, Canada, Croatia, Denmark, Finland, France, Germany, India, Ireland, Italy, Korea, Luxembourg, Malaysia, Netherlands, Portugal, Singapore, Slovakia. Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, and United Kingdom.
  • Descripción del producto
    (1) Sigma HP Cemented Trochlea Size 1 Narrow Left, Catalog Number: 102403100, GTIN: 10603295001614; (2) Sigma HP Cemented Trochlea Size 2 Narrow Left, Catalog Number: 102403200, GTIN: 10603295001621; (3) Sigma HP Cemented Trochlea Size 3 Narrow Left, Catalog Number: 102403300, GTIN: 10603295001638; (4) Sigma HP Cemented Trochlea Size 4 Narrow Left, Catalog Number: 102403400, GTIN: 10603295001645; (5) Sigma HP Cemented Trochlea Size 5 Narrow Left, Catalog Number: 102403500, GTIN: 10603295001652; (6) Sigma HP Cemented Trochlea Size 1 Narrow Right, Catalog Number: 102404100, GTIN: 10603295001669; (7) Sigma HP Cemented Trochlea Size 2 Narrow Right, Catalog Number: 102404200, GTIN: 10603295001676; (8) Sigma HP Cemented Trochlea Size 3 Narrow Right, Catalog Number: 102404300, GTIN: 10603295001683; (9) Sigma HP Cemented Trochlea Size 4 Narrow Right, Catalog Number: 102404400, GTIN: 10603295001690; (10) Sigma HP Cemented Trochlea Size 5 Narrow Right, Catalog Number: 102404500, GTIN: 10603295001706
  • Manufacturer
    DePuy Orthopaedics, Inc.

Manufacturer

DePuy Orthopaedics, Inc.
  • Dirección del fabricante
    DePuy Orthopaedics, Inc., 700 Orthopaedic Dr, Warsaw IN 46582-3994
  • Empresa matriz del fabricante (2017)
    Johnson & Johnson
  • Source
    USFDA