Instrumed International, Inc. Lock nuts for titanium traction tongs are used in traction skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and are sold under the CareFusion, Millennium Surgical, Boss Instruments, and Stealth Surgical 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
Lock nuts for titanium traction tongs are used in traction skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and are sold under the CareFusion, Millennium Surgical, Boss Instruments, and Stealth Surgical brand names
Brand
Instrumed International, Inc.
Lot Codes / Batch Numbers
1) Instrumed Product Name: Lock Nut for Titanium Traction Tongs, Instrumed Product Number: 638-05409, Trade Name: CareFusion, CareFusion Product Name: Gardener-Wells Titanium Fixation Screw, Springloaded, CareFusion Item Number: NL9513-T, Lot Number: 012412. 2) Instrumed Product Name: Lock Nut for Titanium Traction Tongs, Instrumed Product Number: 638-05409, Trade Name: CareFusion, CareFusion Product Name: Gardener-Wells Titanium Traction Tongs Lock Nut, CareFusion Item Number: NL9515-T, Lot Number: 012412. 3) Instrumed Product Name: Lock Nut for Titanium Traction Tongs, Instrumed Product Number: 638-05409, Trade Name: Millennium Surgical, Millennium Surgical Product Name: Gardener-Wells Titanium Traction Tongs Lock Nut, Millennium Surgical Item Number: 6-1944LN, Lot Number: 012412. 4) Instrumed Product Name: Lock Nut for Titanium Traction Tongs, Instrumed Product Number: 638-05409, Trade Name: Boss Instruments, Boss Instruments Product Name: Gardener-Wells Titanium Traction Tongs Lock Nut, Boss Instruments Item Number: 74-0181T, Lot Number: 012412. 5) Instrumed Product Name: Lock Nut for Titanium Traction Tongs, Instrumed Product Number: 638-05409, Trade Name: Stealth Surgical, Stealth Surgical Product Name: Gardener-Wells Titanium Traction Tongs Lock Nut, Stealth Surgical Item Number: SS2195T, Lot Number: 012412. 6) Instrumed Product Name: Lock Nut for Titanium Traction Tongs, Instrumed Product Number: 638-05409, Trade Name: CareFusion, CareFusion Product Name: Gardener-Wells Titanium Traction Tongs Lock Nut, CareFusion Item Number: VM85-12925, Lot Number: 012412.
Products Sold
1) Instrumed Product Name: Lock Nut for Titanium Traction Tongs; Instrumed Product Number: 638-05409; Trade Name: CareFusion; CareFusion Product Name: Gardener-Wells Titanium Fixation Screw, Springloaded; CareFusion Item Number: NL9513-T; Lot Number: 012412. 2) Instrumed Product Name: Lock Nut for Titanium Traction Tongs; Instrumed Product Number: 638-05409; Trade Name: CareFusion; CareFusion Product Name: Gardener-Wells Titanium Traction Tongs Lock Nut; CareFusion Item Number: NL9515-T; Lot Number: 012412. 3) Instrumed Product Name: Lock Nut for Titanium Traction Tongs; Instrumed Product Number: 638-05409; Trade Name: Millennium Surgical; Millennium Surgical Product Name: Gardener-Wells Titanium Traction Tongs Lock Nut; Millennium Surgical Item Number: 6-1944LN; Lot Number: 012412. 4) Instrumed Product Name: Lock Nut for Titanium Traction Tongs; Instrumed Product Number: 638-05409; Trade Name: Boss Instruments; Boss Instruments Product Name: Gardener-Wells Titanium Traction Tongs Lock Nut; Boss Instruments Item Number: 74-0181T; Lot Number: 012412. 5) Instrumed Product Name: Lock Nut for Titanium Traction Tongs; Instrumed Product Number: 638-05409; Trade Name: Stealth Surgical; Stealth Surgical Product Name: Gardener-Wells Titanium Traction Tongs Lock Nut; Stealth Surgical Item Number: SS2195T; Lot Number: 012412. 6) Instrumed Product Name: Lock Nut for Titanium Traction Tongs; Instrumed Product Number: 638-05409; Trade Name: CareFusion; CareFusion Product Name: Gardener-Wells Titanium Traction Tongs Lock Nut; CareFusion Item Number: VM85-12925; Lot Number: 012412.
Instrumed International, Inc. is recalling Lock nuts for titanium traction tongs are used in traction skull tongs for traction used to immobili 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