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
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Instrumed International, Inc.
Lot Codes / Batch Numbers
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, 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, 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, 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, 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, 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.
Products Sold
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.
Instrumed International, Inc. is recalling Gardner-Wells traction tongs are skull tongs for traction used to immobilize a patient with a cervic due to 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, . This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026