Events

Retiro De Equipo (Recall) de Device Recall Biomet Hip Fracture Plating Systems

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 Biomet, 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
    74576
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2240-2016
  • Fecha de inicio del evento
    2016-06-10
  • Fecha de publicación del evento
    2016-07-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-07-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147936
  • 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
    Device, fixation, proximal femoral, implant - Product Code JDO
  • Causa
    The screw may fracture at the junction of the shaft and the head during implantation. the patient may retain a foreign body if the fractured screw cannot be removed. soft tissue irritation will not occur as the retained portion of the screw is below the surface of the plate. a delay in surgery less than 30 minutes may occur.
  • Acción
    Zimmer Biomet sent an Urgent Medical Device Recall letter dated June 10, 2016, to all affected customers via courier. Distributors and hospitals were instructed to locate and return the affected product, and implanting surgeons were instructed to monitor patients. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Questions related to this notice should be directed to (574) 372-6725, Monday through Friday, 8 a.m. to 5 p.m.

Device

Device Recall Biomet Hip Fracture Plating Systems
  • Modelo / Serial
    All Lots.  Part Number / Description:  14-451002 130 DEG 2-HOLE LEFT NECK FX 14-451004 130 DEG 4-HOLE LEFT NECK FX 14-451070 7.5MM TELESCOPE LAG SCR 70MM 14-451075 7.5MM TELESCOPE LAG SCR 75MM 14-451080 7.5MM TELESCOPE LAG SCR 80MM 14-451085 7.5MM TELESCOPE LAG SCR 85MM 14-451090 7.5MM TELESCOPE LAG SCR 90MM 14-451095 7.5MM TELESCOPE LAG SCR 95MM 14-451100 7.5MM TELESCOPE LAG SCR 100MM 14-451102 130 DEG 2-HOLE RIGHT NECK FX 14-451104 130 DEG 4-HOLE RIGHT NECK FX 14-451105 7.5MM TELESCOPE LAG SCR 105MM 14-451110 7.5MM TELESCOPE LAG SCR 110MM 14-451115 7.5MM TELESCOPE LAG SCR 115MM 14-451120 7.5MM TELESCOPE LAG SCR 120MM 14-451125 7.5MM TELESCOPE LAG SCR 125MM 14-451130 7.5MM TELESCOPE LAG SCR 130MM 14-451500 ANGLE GUIDE 130 DEG 14-451502 GUIDE WIRE 3.0MM 14-451503 GUIDE PIN DRIVER 3.0MM 14-451504 TARGETING GUIDE 130 DEG LEFT 14-451505 TARGETING GUIDE 130 DEG RIGHT 14-451509 JIG ATTACHMENT DRIVER 3.5MM 14-451510 NON-LOCK GUIDE SLEEVE 7.5MM 14-451511 LOCKING GUIDE SLEEVE 7.5MM 14-451512 ENTRY TROCAR 7.5 MM 14-451513 DRILL BIT 3.0MM 14-451525 GUIDE WIRE DEPTH GAUGE 3.0MM 14-451526 STEP DRILL CANNULATED 7.5MM 14-451527 STEP DRILL NON-CANN 7.5MM 14-451528 TSP HIP FX TAP 7.5MM 14-451529 HEX DRIVER NECK SLEEVE 5.0MM 14-451530 DRIVER CONNECTOR SHAFT 5.0MM 14-451531 HEX DRIVER NECK SHAFT 3.5MM 14-451532 INSERTER LIMITED COLLAPSE 14-451533 DEPTH GAUGE LIMITED COLLAPSE 14-451535 SCREW GUIDE SLEEVE 4.5MM 14-451536 TROCAR 4.5MM SCREW 14-451537 DRILL GUIDE LOCKING 3.5MM 14-451538 DRILL GUIDE NON-LOCK 3.5MM 14-451539 DRILL BIT 3.5MM 14-451540 SCREW DEPTH GAUGE 4.5MM 14-451541 SCREW DEPTH GAUGE HOOK 4.5MM 14-451542 TSP HIP FX CORTICAL TAP 4.5MM 14-451543 DRIVER 5.0 HEX/3.5 HEXALOBE 14-451544 CONNECTOR SHAFT 4.5MM SCREW 14-451546 T HANDLE W/ HUDSON 14-451550 IMPACTION HANDLE 14-451551 IMPACTION GUIDE PAD 14-451552 IMPACTION PLATE PAD 14-451554 GUIDE WIRE ALIGNMENT ARM 14-451560 GUIDE WIRE PUSHER 2.8MM 14-451561 GUIDE WIRE PLACEMENT TROCAR 14-451562 GUIDE WIRE PLACEMENT SLEEVE 14-451565 SCREW EXTRACTOR 7.5MM SCREW 14-451567 SCREW EXTRACTOR 4.5MM SCREW 14-451568 LAG SCREW REMOVAL TOOL 7.5MM 14-451570 BONE HOOK 14-451571 BALL SPIKE PUSHER 14-451573 REDUCTION TOOL 14-451580 NECK FX INSTRUMENT CASE 14-453005 LIMITED COLLAPSE SLEEVE 5MM 14-453010 LIMITED COLLAPSE SLEEVE 10MM 14-453015 LIMITED COLLAPSE SLEEVE 15MM 14-453020 LIMITED COLLAPSE SLEEVE 20MM 14-454014 4.5MM CORT LOCK SCREW 14MM 14-454016 4.5MM CORT LOCK SCREW 16MM 14-454018 4.5MM CORT LOCK SCREW 18MM 14-454020 4.5MM CORT LOCK SCREW 20MM 14-454022 4.5MM CORT LOCK SCREW 22MM 14-454024 4.5MM CORT LOCK SCREW 24MM 14-454026 4.5MM CORT LOCK SCREW 26MM 14-454028 4.5MM CORT LOCK SCREW 28MM 14-454030 4.5MM CORT LOCK SCREW 30MM 14-454032 4.5MM CORT LOCK SCREW 32MM 14-454034 4.5MM CORT LOCK SCREW 34MM 14-454036 4.5MM CORT LOCK SCREW 36MM 14-454038 4.5MM CORT LOCK SCREW 38MM 14-454040 4.5MM CORT LOCK SCREW 40MM 14-454042 4.5MM CORT LOCK SCREW 42MM 14-454044 4.5MM CORT LOCK SCREW 44MM 14-454046 4.5MM CORT LOCK SCREW 46MM 14-454048 4.5MM CORT LOCK SCREW 48MM 14-454050 4.5MM CORT LOCK SCREW 50MM 14-454052 4.5MM CORT LOCK SCREW 52MM 14-454054 4.5MM CORT LOCK SCREW 54MM 14-454056 4.5MM CORT LOCK SCREW 56MM 14-454058 4.5MM CORT LOCK SCREW 58MM 14-454060 4.5MM CORT LOCK SCREW 60MM 14-454065 4.5MM CORT LOCK SCREW 65MM 14-454070 4.5MM CORT LOCK SCREW 70MM 14-454075 4.5MM CORT LOCK SCREW 75MM 14-454080 4.5MM CORT LOCK SCREW 80MM 14-454085 4.5MM CORT LOCK SCREW 85MM 14-454090 4.5MM CORT LOCK SCREW 90MM 14-454095 4.5MM CORT LOCK SCREW 95MM 14-455014 4.5MM CORT NON-LOCK SCREW 44MM 14-455016 4.5MM CORT NON-LOCK SCREW 16MM 14-455018 4.5MM CORT NON-LOCK SCREW 18MM 14-455020 4.5MM CORT NON-LOCK SCREW 20MM 14-455022 4.5MM CORT NON-LOCK SCREW 22MM 14-455024 4.5MM CORT NON-LOCK SCREW 24MM 14-455026 4.5MM CORT NON-LOCK SCREW 26MM 14-455028 4.5MM CORT NON-LOCK SCREW 28MM 14-455030 4.5MM CORT NON-LOCK SCREW 30MM 14-455032 4.5MM CORT NON-LOCK SCREW 32MM 14-455034 4.5MM CORT NON-LOCK SCREW 34MM 14-455036 4.5MM CORT NON-LOCK SCREW 36MM 14-455038 4.5MM CORT NON-LOCK SCREW 38MM 14-455040 4.5MM CORT NON-LOCK SCREW 40MM 14-455042 4.5MM CORT NON-LOCK SCREW 42MM 14-455044 4.5MM CORT NON-LOCK SCREW 44MM 14-455046 4.5MM CORT NON-LOCK SCREW 46MM 14-455048 4.5MM CORT NON-LOCK SCREW 48MM 14-455050 4.5MM CORT NON-LOCK SCREW 50MM 14-455052 4.5MM CORT NON-LOCK SCREW 52MM 14-455054 4.5MM CORT NON-LOCK SCREW 54MM 14-455056 4.5MM CORT NON-LOCK SCREW 56MM 14-455058 4.5MM CORT NON-LOCK SCREW 58MM 14-455060 4.5MM CORT NON-LOCK SCREW 60MM 14-455065 4.5MM CORT NON-LOCK SCREW 65MM 14-455070 4.5MM CORT NON-LOCK SCREW 70MM 14-455075 4.5MM CORT NON-LOCK SCREW 75MM 14-455080 4.5MM CORT NON-LOCK SCREW 80MM 14-455085 4.5MM CORT NON-LOCK SCREW 85MM 14-455090 4.5MM CORT NON-LOCK SCREW 90MM 14-455095 4.5MM CORT NON-LOCK SCREW 95MM
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - US (Nationwide) Internationally to Australia, The Netherlands, and Japan
  • Descripción del producto
    TSP Hip Fracture Plating System || device, fixation, proximal femoral, implant || The Biomet Hip Fracture Plating Systems are indicated for use in the open reduction and internal fixation of a wide variety of fractures of the proximal femur: intracapsular fractures and intertrochanteric fractures. Fracture plates with six or more femoral shaft fixation screw holes are also indicated for subtrochanteric fractures as well as proximal femoral osteotomies
  • Manufacturer
    Biomet, Inc.

Manufacturer

Biomet, Inc.
  • Dirección del fabricante
    Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582-6989
  • Empresa matriz del fabricante (2017)
    Zimmer Biomet Holdings
  • Comentario del fabricante
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    USFDA