Instrumed International, Inc.: 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.

Recall number

Z-0550-2015

Recalling firm

Instrumed International, Inc.

Product

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.

Status

Terminated

Initiated

2014-09-08

Posted

2014-12-16

Terminated

2017-11-29

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The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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

Root cause

No Marketing Application

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.

Quantity

190 Gardner-Wells traction tongs

Distribution

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

Lot, serial or model codes

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.

510(k) numbers

not on file

PMA numbers

not on file

Product code

HAX

Firm FEI

1421101

Firm city

Schaumburg

Firm state

IL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

Copy