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Instrumed International, Inc. recalls Gardner-Wells traction tongs are skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g
Recalled December 17, 2014 · FDA recall Z-0550-2015 · Instrumed International
Hazard
The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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. · FDA Class II
Units
190 Gardner-Wells traction tongs
Sold at
Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.
Description
The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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.
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.
Manufacturer(s)
Instrumed International, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →