The Recall Desk
LowFDA (Devices)·Z-0552-2015·Announced 2014-12-17

Instrumed Recalls Lock Nuts for Titanium Traction Tongs

Instrumed International is withdrawing 49 lock nuts for titanium traction tongs because the devices were not marketed prior to September 26, 1976, and do not meet FDA pre-amendment requirements.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is driven by regulatory compliance regarding pre-amendment status rather than a physical defect or reported injury, fitting the criteria for documentation issues or low-risk administrative recalls.

Plain-English summary

Instrumed International, Inc. is withdrawing 49 lock nuts for titanium traction tongs from the market. These devices are used in traction skull tongs to immobilize patients with cervical spine injuries, such as fractures or dislocations. The products are sold under the CareFusion, Millennium Surgical, Boss Instruments, and Stealth Surgical brand names.

The reason for this withdrawal is that Instrumed did not market these devices prior to September 26, 1976. Consequently, the devices do not meet all FDA requirements to be marketed as "Pre-Amendment" devices. The affected lot number is 012412.

The devices were distributed nationwide, including in Arizona, California, Florida, Illinois, Kansas, Michigan, North Carolina, Ohio, Pennsylvania, Tennessee, Texas, and Virginia. Healthcare facilities and consumers should stop using these specific lock nuts and contact Instrumed International for further instructions.

The recalled product

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
Manufacturer
Instrumed International, Inc.
Category
Medical Device — Orthopedic / Traction
Hazard
Affected units
49

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (18)

  • 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
  • CareFusion Product Name: Gardener-Wells Titanium Traction Tongs Lock Nut
  • CareFusion Item Number: NL9515-T
  • Trade Name: Millennium Surgical
  • Millennium Surgical Item Number: 6-1944LN
  • Trade Name: Boss Instruments
  • Boss Instruments Product Name: Gardener-Wells Titanium Traction Tongs Lock Nut
  • Boss Instruments Item Number: 74-0181T
  • Trade Name: Stealth Surgical
  • Stealth Surgical Product Name: Gardener-Wells Titanium Traction Tongs Lock Nut
  • Stealth Surgical Item Number: SS2195T
  • CareFusion Item Number: VM85-12925
  • Lot Number: 012412.

Distribution

Distributed nationwide across the United States.

The notice also names 12 states specifically:

Part of a larger recall action

This product is one of 28 recalled by Instrumed International, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 28 products in this recall →

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