Events

Recall of SPS Blue Line Tube Clamp Adapters

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Southern Prosthetic Supply Co..

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
    36626
  • Event Risk Class
    Class 2
  • Event Number
    Z-0445-2007
  • Event Initiated Date
    2006-10-03
  • Event Date Posted
    2007-01-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-03-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49024
  • 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
    Tube Clamp adapters - Product Code ISH
  • Reason
    Device fracturing: recent design and process changes leave the device susceptible to fracturing, which could cause the prosthesis to fail.
  • Action
    On October 6, 2006, SPS faxed a recall notification to the 187 customers who had purchased one or more BL120M Tube Clamp Adapters from SPS between August 29 and September 20, 2006. On October 9, SPS contacted those customers that had purchased five or more Adapters via telephone to confirm they had received the faxed recall notification. On October 10, SPS mailed another copy of the recall notification, via certified mail, return receipt requested to all of its customers that had purchased one or more BL120M Tube Clamp Adapters. The customers were told to send the BL120M Adapter back to SPS following replacement.

Device

SPS Blue Line Tube Clamp Adapters
  • Model / Serial
    Product number BL120M, with the letters, ''SPS'' etched into the product
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    SPS Blue Line Tube Clamp Adapters, Product No. BL120M
  • Manufacturer
    Southern Prosthetic Supply Co.

Manufacturer

Southern Prosthetic Supply Co.
  • Manufacturer Address
    Southern Prosthetic Supply Co., 6025 Shiloh Rd Ste A, Alpharetta GA 30005-1706
  • Source
    USFDA