Events

Recall of Device Recall Exogen Express Bone Healing System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Smith & Nephew 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
    52228
  • Event Risk Class
    Class 2
  • Event Number
    Z-1696-2009
  • Event Initiated Date
    2009-06-05
  • Event Date Posted
    2009-08-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-11-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82573
  • 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
    Exogen Express Bone Healing System - Product Code LPQ
  • Reason
    Problems with transducer may result in a reduced ultrasound output.
  • Action
    All affected Smith & Nephew consignees and distributors were notified of problem and the recall by letters (dated June 5, 2009 and June 8, 2009) via US mail. Patients were directed to return the instruments; physicians were informed that their patients were being contacted; and distributors were requested to return their stock and to notify anyone to whom the product was distributed to also return the product. Direct questions to Smith & Nephew, Inc. by calling at 1-800-836-4080.

Device

Device Recall Exogen Express Bone Healing System
  • Model / Serial
    Part number 71034200 (system), Serial numbers: 0408017701, 0408017702, 0408017703, 0408017704, 0408017705, 0408017706, 0408017707, 0408017708, 0408017709, 0408017710, 0408017711, 0408017712, 0408017713, 0408017714, 0408017715, 0408017716, 0408017717, 0408017718, 0408017719, 0408017720, 0408017721, 0408017722, 0408017723, 0408017724, 0408017725, 0408017726, 0408017727, 0408017728, 0408017729, 0408017730, 0408017731, 0408017732, 0408017733, 0408017734, 0408017735, 0408017736, 0408017737, 0408017738, 0408017739, 0408017740, 0408017741, 0408017742, 0408017743, 0408017744, 0408017745, 0408017746, 0408017747, 0408017748, 0408017749, 0408017750, 0109000456, 0109000457, 0109000458, 0109000459, 0109000461, 0109000485, 0109000495 and 0109000496 and  Exogen Express Part number 71034140 (device only), Serial numbers: 0408017129, 0408017132, 0408017133, 0408017138, 0408017147, 0408017155, 0408017157, 0408017158, 0408017161, 0408017162, 0408017168, 0408017171, 0408017175, 0408017178, 0408017184, 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  • Product Classification
    Orthopedic Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US, Switzerland, Canada, Malaysia, Japan, and UK.
  • Product Description
    Exogen Express Bone Healing System, SAFHS, Part Numbers 71034200 and 71034140, Rx only, Smith & Nephew, 1450 Brooks Road, Memphis TX 38116. These are distributed internationally only. || The device is used for the non-invasive treatment of established nonunions excluding skull and vertebra.
  • Manufacturer
    Smith & Nephew Inc

Manufacturer

Smith & Nephew Inc
  • Manufacturer Address
    Smith & Nephew Inc, 1450 E. Brooks Rd, Memphis TN 38116
  • Manufacturer Parent Company (2017)
    Smith & Nephew plc
  • Source
    USFDA