Gardner-Wells traction tongs are skull tongs for traction used to immobilize a patient with a cer...
FDA Device Recall #Z-0550-2015 — Class II — September 8, 2014
Recall Summary
| Recall Number | Z-0550-2015 |
| Classification | Class II — Moderate risk |
| Date Initiated | September 8, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Instrumed International, Inc. |
| Location | Schaumburg, IL |
| Product Type | Devices |
| 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The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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.
Lot / 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.
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Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.