FDAFDA · Food and drugs·Recall number Z-0552-2015
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
Published December 17, 2014 · Recall initiated: September 8, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Instrumed International, Inc.
- Distributor
- Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.