Events

Recall of Milenium Surgical, Echo Instruments, Adler Instrument, Surgical Direct, Stealth Surgical, etc.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Instrumed International, 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
    69471
  • Event Risk Class
    Class 2
  • Event Number
    Z-0550-2015
  • Event Initiated Date
    2014-09-08
  • Event Date Posted
    2014-12-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-11-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131328
  • 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
    Tong, skull for traction - Product Code HAX
  • Reason
    The reason these devices are being withdrawn from the market by instrumed is that instrumed did not market these devices prior to september 26, 1976, and therefore, does not meet all fda requirements to market the devices as "pre-amendment" devices.
  • Action
    Instrumed sent an URGENT: MEDICAL DEVICE MARKET WITHDRAWAL letters dated October 9, 2014 to all affected customers. The letter included instructions for customers to: 1) examine their inventory to determine if there are any recalled devices; 2) complete and return the enclosed Confirmation Request Form; 3) return the recalled devices; and 4) share the recall information with facility staff. Customers with questions were instructed to contact Instrumed by telephone at 847-908-6119.

Device

Milenium Surgical, Echo Instruments, Adler Instrument, Surgical Direct, Stealth Surgical, etc.
  • Model / Serial
    1) Instrumed Product Name: Gardner-Wells Traction Tongs Complete; Instrumed Product Number: 630-05401; Trade Name: Millenium Surgical; Millenium Surgical Product Name: Gardner-Wells Traction Tongs Complete; Millenium Surgical Item Number: 12-661025; Lot Numbers: 040313, 070512.   2) Instrumed Product Name: Gardner-Wells Traction Tongs Complete; Instrumed Product Number: 630-05401; Trade Name: Echo Instruments; Echo Instruments Product Name: Gardner-Wells Traction Tongs Complete; Echo Instruments Item Number: 576-804; Lot Numbers: 050413, 110212.   3) Instrumed Product Name: Gardner-Wells Traction Tongs Complete; Instrumed Product Number: 630-05401; Trade Name: Millenium Surgical; Millenium Surgical Product Name: Gardner-Wells Traction Tongs Complete; Millenium Surgical Item Number: 6-1945; Lot Numbers: 030314, 040313, 050413, 110212.   4) Instrumed Product Name: Gardner-Wells Traction Tongs Complete; Instrumed Product Number: 630-05401; Trade Name: Adler Instrument; Adler Instrument Product Name: Gardner-Wells Traction Tongs Complete; Adler Instrument Item Number: ADR1945; Lot Number: 050413.   5) Instrumed Product Name: Gardner-Wells Traction Tongs Complete; Instrumed Product Number: 630-05401; Trade Name: Surgical Direct; Surgical Direct Product Name: Gardner-Wells Traction Tongs Complete; Surgical Direct Item Number: SD5861.100; Lot Number: 050413.   6) Instrumed Product Name: Gardner-Wells Traction Tongs Complete; Instrumed Product Number: 630-05401; Trade Name: Stealth Surgical; Stealth Surgical Product Name: Gardner-Wells Traction Tongs Complete; Stealth Surgical Item Number: SS2191; Lot Number: 110212.   7) Instrumed Product Name: Gardner-Wells Traction Tongs Complete; Instrumed Product Number: 630-05401; Trade Name: CareFusion; CareFusion Product Name: Gardner-Wells Traction Tongs Complete; CareFusion Item Number: VM85-1291; Lot Numbers: 030314, 040313, 050413, 050512, 070212, 070512, 110212.   8) Instrumed Product Name: Gardner-Wells Traction Tongs Complete; Instrumed Product Number: 630-05401; Trade Name: CareFusion; CareFusion Product Name: Gardner-Wells Traction Tongs Set; CareFusion Item Number: NL9500; Lot Numbers: 030314, 040313, 050413, 050512, 050514, 060514, 070212, 110212.   9) Instrumed Product Name: Gardner-Wells Traction Tongs Complete; Instrumed Product Number: 630-05401; Trade Name: Boss Instruments; Boss Instruments Product Name: Gardner-Wells Traction Tongs Complete; Boss InstrumentsItem Number: 74-0180; Lot Numbers: 030314, 040313, 050413, 070512.   10) Instrumed Product Name: Gardner-Wells Traction Tongs Titanium Small 7" Opening; Instrumed Product Number: 638-05401; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Gardner-Wells Traction Tongs Titanium Small 7" Opening; Symmetry Surgical Item Number: 57-6804T; Lot Number: 070512.   11) Instrumed Product Name: Gardner-Wells Traction Tongs Titanium Small 7" Opening; Instrumed Product Number: 638-05401; Trade Name: Millennium Surgical; Millennium Surgical Product Name: Gardner-Wells Traction Tongs Titanium Small 7" Opening; Millennium Surgical Item Number: 6-1944; Lot Numbers: 060413, 070512, 100211.   12) Instrumed Product Name: Gardner-Wells Traction Tongs Titanium Small 7" Opening; Instrumed Product Number: 638-05401; Trade Name: Adler Instrument; Adler Instrument Product Name: Gardner-Wells Traction Tongs Titanium Small 7" Opening; Adler Instrument Item Number: ADR1944; Lot Number: 110312.   13) Instrumed Product Name: Gardner-Wells Traction Tongs Titanium Small 7" Opening; Instrumed Product Number: 638-05401; Trade Name: CareFusion; CareFusion Product Name: Gardner-Wells Traction Tongs Titanium Small 7" Opening; CareFusion Item Number: VM85-12915; Lot Numbers: 020411, 050412, 070512, 100211.   14) Instrumed Product Name: Gardner-Wells Traction Tongs Titanium Small 7" Opening; Instrumed Product Number: 638-05401; Trade Name: CareFusion; CareFusion Product Name: Gardner-Wells Titanium Traction Tongs, Small Opening 7" (17.8 CM); CareFusion Item Number: NL9510-T; Lot Numbers: 060413, 070512, 100211, 110312.   15) Instrumed Product Name: Gardner-Wells Traction Tongs Titanium Small 7" Opening; Instrumed Product Number: 638-05401; Trade Name: Boss Instruments; Boss Instruments Product Name: Gardner-Wells Traction Tongs, Complete; Boss Instruments Item Number: 74-0180T; Lot Numbers: 070512, 110312.   16) Instrumed Product Name: Gardner-Wells Traction Tongs Titanium Medium 7 1/2" Opening; Instrumed Product Number: 638-05433; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Gardner-Wells Traction Tongs, Medium 7 1/2" Opening; Symmetry Surgical Item Number: 57-6803T; Lot Numbers: 050412, 110312.   17) Instrumed Product Name: Gardner-Wells Traction Tongs Titanium Medium 7 1/2" Opening; Instrumed Product Number: 638-05433; Trade Name: Millennium Surgical; Millennium Surgical Product Name: Gardner-Wells Traction Tongs, Medium 7 1/2" Opening; Millennium Surgical Item Number: 6-1944MD; Lot Numbers: 070512, 110312.   18) Instrumed Product Name: Gardner-Wells Traction Tongs Titanium Medium 7 1/2" Opening; Instrumed Product Number: 638-05433; Trade Name: Boss Instruments; Boss Instruments Product Name: Gardner-Wells Traction Tongs, Medium 7 1/2" Opening; Boss Instruments Item Number: 74-0186T; Lot Numbers: 070512, 100112, 100211, 100212.   19) Instrumed Product Name: Gardner-Wells Traction Tongs Titanium Medium 7 1/2" Opening; Instrumed Product Number: 638-05433; Trade Name: Stealth Surgical; Stealth Surgical Product Name: Gardner-Wells Traction Tongs, Medium 7 1/2" Opening; Stealth Surgical Item Number: SS2197T; Lot Number: 100112.   20) Instrumed Product Name: Gardner-Wells Traction Tongs Titanium Medium 7 1/2" Opening; Instrumed Product Number: 638-05433; Trade Name: CareFusion; CareFusion Product Name: Gardner-Wells Traction Tongs, Medium 7 1/2" Opening; CareFusion Item Number: VM85-12975; Lot Number: 050412, 100211.   21) Instrumed Product Name: Gardner-Wells Traction Tongs Titanium Medium 7 1/2" Opening; Instrumed Product Number: 638-05433; Trade Name: CareFusion; CareFusion Product Name: Gardner-Wells Titanium Traction Tongs, Medium Opening 7-1/2" (19 CM); CareFusion Item Number: NL9511-T; Lot Number: 070512.   22) Instrumed Product Name: Gardner-Wells Traction Tongs Titanium Large 8" Opening; Instrumed Product Number: 638-05437; Trade Name: Millennium Surgical; Millennium Surgical Product Name: Gardner-Wells Titanium Traction Tongs, Large 8" Opening; Millennium Surgical Item Number: 6-1944LG; Lot Number: 050413.   23) Instrumed Product Name: Gardner-Wells Traction Tongs Titanium Large 8" Opening; Instrumed Product Number: 638-05437; Trade Name: Boss Instruments; Boss Instruments Product Name: Gardner-Wells Titanium Traction Tongs, Large 8" Opening; Boss Instruments Item Number: 74-0188T; Lot Numbers: 020512, 040114, 050412, 050413, 070512, 100212.   24) Instrumed Product Name: Gardner-Wells Traction Tongs Titanium Large 8" Opening; Instrumed Product Number: 638-05437; Trade Name: Stealth Surgical; Stealth Surgical Product Name: Gardner-Wells Titanium Traction Tongs, Large 8" Opening; Stealth Surgical Item Number: SS2198T; Lot Numbers: 040114, 050413, 070512.   25) Instrumed Product Name: Gardner-Wells Traction Tongs Titanium Large 8" Opening; Instrumed Product Number: 638-05437; Trade Name: CareFusion; CareFusion Product Name: Gardner-Wells Titanium Traction Tongs, Large 8" Opening; CareFusion Item Number: VM85-12995; Lot Numbers: 020512, 100212, 120413.   26) Instrumed Product Name: Gardner-Wells Traction Tongs Titanium Large 8" Opening; Instrumed Product Number: 638-05437; Trade Name: CareFusion; CareFusion Product Name: Gardner-Wells Titanium Traction Tongs, Large 8" Opening; CareFusion Item Number: VM85-12995; Lot Numbers: 020512, 100212, 120413.   27) Instrumed Product Name: Gardner-Wells Traction Tongs Titanium Large 8" Opening; Instrumed Product Number: 638-05437; Trade Name: CareFusion; CareFusion Product Name: Gardner-Wells Titanium Traction Tongs, Large 8" Opening (20.3 CM); CareFusion Item Number: NL9512-T; Lot Numbers: 020512, 040114, 050412, 050413, 070213, 120413.
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.
  • Product Description
    Gardner-Wells traction tongs are skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and sold under the Millenium Surgical, Echo Instruments, Adler Instrument, Surgical Direct, Stealth Surgical, CareFusion, and Boss Instruments brand names.
  • Manufacturer
    Instrumed International, Inc.

Manufacturer

Instrumed International, Inc.
  • Manufacturer Address
    Instrumed International, Inc., 626 Cooper Ct, Schaumburg IL 60173-4537
  • Manufacturer Parent Company (2017)
    Avalign Technologies Inc.
  • Source
    USFDA