Home / Recalls / Instrumed International, Inc. / Z-0550-2015

Z-0550-2015 Class II Terminated

Recalled by Instrumed International, Inc. — Schaumburg, IL

Recall Details

Product Type
Devices
Report Date
December 17, 2014
Initiation Date
September 8, 2014
Termination Date
November 29, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
190 Gardner-Wells traction tongs

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.

Reason for Recall

The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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.

Distribution Pattern

Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.

Code Information

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.

Other recalls by Instrumed International, Inc.

  • Z-0532-2015 Class II — A uterine tenaculum is a hook-like instrument used to seize and hold the cervix (September 8, 2014)
  • Z-0533-2015 Class II — An endometrial suction curette is a device used to remove material from the uter (September 8, 2014)
  • Z-0559-2015 Class II — Schoitz weights are manual devices used with Schoitz tonometers and are intended (September 8, 2014)
  • Z-0544-2015 Class II — Hudson burrs are bone cutting and drilling instruments that are used without a p (September 8, 2014)
  • Z-0534-2015 Class II — A zipser clamp is an instrument used to compress reduce blood flow to the penis (September 8, 2014)
  • Z-0538-2015 Class II — A circumcision clamp is an instrument used to compress the foreskin of the penis (September 8, 2014)
  • Z-0541-2015 Class II — Hudson cerebellar extensions are bone cutting and drilling instruments that are (September 8, 2014)
  • Z-0549-2015 Class II — Galt trephines are bone cutting and drilling instruments that are used without a (September 8, 2014)
  • Z-0535-2015 Class II — A trocar is a sharp-pointed instrument used with a cannula for piercing a vessel (September 8, 2014)
  • Z-0536-2015 Class II — An external vein stripper is an extravascular device used to remove a section of (September 8, 2014)