Events

Recall of Device Recall Fixion Interlocking Proximal Femoral Intramedullary Nailing System (Fixion PF Nail) Hip Peg

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Disc Orthopaedic Technologies 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
    25800
  • Event Risk Class
    Class 3
  • Event Number
    Z-0943-03
  • Event Initiated Date
    2002-12-11
  • Event Date Posted
    2003-06-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-04-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26491
  • 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
    Nail, Fixation, Bone, Metallic - Product Code NDH
  • Reason
    The fixion interlocking proximal femoral hip pegs are defective due to possible tension failure.
  • Action
    The first letter, dated Monday October 14, 2002, went out to 10 of the firm''s agents who directly handled this line of product. The firm then sent out a follow-up letter, dated Wednesday December 11, 2002, to the same agents that they had previously made contact with to assure their knowledge regarding the recall.

Device

Device Recall Fixion Interlocking Proximal Femoral Intramedullary Nailing System (Fixion PF Nail...
  • Model / Serial
    Catalog # Lot # -- 4418080--PF02385;  PF02437;  PF02477;  PF02696;  PF02697;  PF02695;  PF02378;  PF02333;   4408080-- FP-1161;  FP-1094;  FP01176;  FP-1089;   4408081-- PF02333;   4418090-- PF02701;  PF02700;  PF02478;  PF02438;  PF02640;   4408101-- PF02335;   4418105-- PF02336;   4408111-- PF02193;   4418110-- PF02713;  PF02712;  PF02709;  PF02641;  PF02495;  PF02480;  PF02440;  PF02387;  PF02380;   4408110-- FP01175;  FP-1147;  FP-1097;  FP-1092;   4408090-- FP01179;  FP-1163;  FP-1095;  FP-1090;  271201;   4408091-- PF02192;   4418095-- PF02334;   4408100-- FP-1096;  FP-1091;  FP01178;  FP-1160;   4418100-- PF02335;  PF02707;  PF02371;  PF02379;  PF02386;  PF02439;  PF02479;  PF02703;  PF02705;  PF02706;   4418120-- PF02715;  PF02714;  PF02539;  PF02441;  PF02388;  PF02381;  PF02372;  PF02337;   4408120-- FP01177;  FP-1162;  FP-1098;  FP-1093;   4408121-- PF02337.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Product is manufactured at Disc-O-Tech Medical Technologies Ltd. located at 3 Hasadnaot St., Herzliya 46728, Israel. Product is then distributed to the rest of the world including the U.S.A. Products enter the U.S.A. through Port Elizabeth, New Jersey. The firm''s U.S.A. importer and distributor is Disc Orthopaedic Technologies, Inc., located at 101 Interchange Plaza, Cranbury, NJ 08512. Disc Orthopaedic Technologies, Inc., then distributes the product to their Agent Principles, employees of Disc Orthopaedic Technologies, Inc., throughout the U.S.A. Each agent principle then distributes the product to their sales representative who then sells the product to customers, primarily consisting of surgeons. Product is maintained with the sales representative and is only sold to a customer on an as needed basis. Customers do not have stock of product maintained at hospitals. Hospitals are located nationwide.
  • Product Description
    Fixion PF (''Proximal Femur'') Hip Peg. Fixion PF Hip Pegs are manufactured in the following various lengths; 80mm, 81mm, 90mm, 91mm, 100mm, 101mm, 105mm, 110mm, 111mm, 120mm, and 121mm. The Fixion PF Hip Peg is intended for use in the fixation of proximal fractures in the femur.
  • Manufacturer
    Disc Orthopaedic Technologies Inc

Manufacturer

Disc Orthopaedic Technologies Inc
  • Manufacturer Address
    Disc Orthopaedic Technologies Inc, 101 Interchange Plaza, Cranbury NJ 085123716
  • Source
    USFDA