CLASS II Device recall · Reported 17 Dec 2014 · FDA Enforcement Report

Lock nuts for titanium traction tongs are used recalled

Instrumed International is recalling Lock nuts for titanium traction tongs are used in traction skull tongs for traction used, distributed nationwide in the US. The recall was initiated on 8 Sep 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes1) 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.

Quantity recalled49 lock nuts for titanium traction tongs

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0552-2015
FDA event ID: 69471
Recalling firm: Instrumed International, Schaumburg, IL
Classification: Class II
Status: Terminated
Recall initiated: 8 Sep 2014
FDA classified: 8 Dec 2014
Reported: 17 Dec 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Spinal Implants

Timeline

8 Sep 2014	Recall initiated by company
8 Dec 2014	Classified by FDA	+91 days
17 Dec 2014	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.

Nationwide Arizona California Florida Illinois Kansas Michigan North Carolina Ohio Pennsylvania Tennessee Texas Virginia

Questions about this recall

Is Lock nuts for titanium traction tongs are used in traction skull tongs for traction used recalled?

Yes. Instrumed International recalled Lock nuts for titanium traction tongs are used in traction skull tongs for traction used on 8 Sep 2014. The recall is Class II and its status is Terminated. Recall number Z-0552-2015.

Why was it recalled?

Which lots are affected?

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.

Where was it sold?

Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Instrumed International

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Reported	Class	Recall	Company	Reason	Where
17 Dec 2014Device	CLASS II	Hudson braces are bone cutting recalled by Instrumed International	Instrumed International	Device Malfunction	Nationwide
17 Dec 2014Device	CLASS II	Replacement screw non-springloaded traction tongs are skull recalled	Instrumed International	Device Malfunction	Nationwide
17 Dec 2014Device	CLASS II	Traction tong replacement screws recalled by Instrumed International	Instrumed International	Device Malfunction	Nationwide
17 Dec 2014Device	CLASS II	Hudson cerebellar extensions are bone cutting recalled	Instrumed International	Device Malfunction	Nationwide
17 Dec 2014Device	CLASS II	Manual trephines are bone cutting recalled by Instrumed International	Instrumed International	Device Malfunction	Nationwide

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