Events

Recall of Device Recall Smith & Nephew, Well Leg Holder

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Smith & Nephew, Inc Endoscopy Division.

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
    37792
  • Event Risk Class
    Class 3
  • Event Number
    Z-0872-2007
  • Event Initiated Date
    2006-11-01
  • Event Date Posted
    2007-06-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-06-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51542
  • 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
    Well Leg Holder (Arthroscopic Accessory) - Product Code NBH
  • Reason
    The device was not manufactured to correct specification causing interference when used in conjunction with patient transfer board.
  • Action
    Firm notified consignees by letter and phone call on 11/1/2006. Consignees asked to return out-of-spec Well Leg Holder for a replacement.

Device

Device Recall Smith & Nephew, Well Leg Holder
  • Model / Serial
    Serial #s: 286092, 287285, 287287, 287288, 287289, 287290, 287291, 289740, 289743, 290456, 290457 and 290837.
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution: USA including states of WI, CA, MO, IL, TX, MA, WA, NM, FL, NH, and SC and the UK
  • Product Description
    Well Leg Holder With Boot, part of the Supine Universal Hip Distractor System; Ref (Part) #72200632; Manufactured for Smith & Nephew, Inc., Endoscopy Divsion, Andover, MA 01810.
  • Manufacturer
    Smith & Nephew, Inc Endoscopy Division

Manufacturer

Smith & Nephew, Inc Endoscopy Division
  • Manufacturer Address
    Smith & Nephew, Inc Endoscopy Division, 76 S. Meridian Ave, Oklahoma City OK 73107-6512
  • Source
    USFDA