The Recall Desk
LowFDA (Devices)·Z-0551-2015·Announced 2014-12-17

Instrumed Recalls Non-Springloaded Traction Tongs for Regulatory Compliance

Instrumed International is withdrawing 67 replacement screw non-springloaded traction tongs because the company did not market them prior to 1976, failing to 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 documentation and marketing compliance issues (failure to meet pre-amendment requirements) rather than a reported safety defect, injury, or contamination, aligning with the 'Low' severity criteria for documentation issues.

Plain-English summary

Instrumed International, Inc. is voluntarily withdrawing 67 replacement screw non-springloaded traction tongs from the market. These devices are skull tongs used to immobilize patients with cervical spine injuries, such as fractures or dislocations. The products were sold under the brand names CareFusion, Boss Instruments, Millennium Surgical, Prezio Health, and Stealth Surgical.

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. This is a regulatory compliance issue rather than a report of a specific safety defect or injury.

The affected units were distributed nationwide, including in Arizona, California, Florida, Illinois, Kansas, Michigan, North Carolina, Ohio, Pennsylvania, Tennessee, Texas, and Virginia. Specific lot numbers and item numbers are listed in the official recall notice. Healthcare facilities and distributors should check their inventory for these specific product numbers and lot numbers and stop using the affected devices.

The recalled product

Product
Replacement screw non-springloaded 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 CareFusion, Boss Instruments, Millennium Surgical, Prezio Health, and Stealth Surgical bran
Manufacturer
Instrumed International, Inc.
Category
Medical Device — Orthopedic / Trauma
Hazard
Affected units
67

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 (20)

  • 1) Instrumed Product Name: Replacement Screw Non-Springloaded
  • Traction Tong
  • Instrumed Product Number: 630-05429
  • Trade Name: CareFusion
  • CareFusion Item Number: NL9506
  • Lot Numbers: 010113
  • 020512
  • 050514
  • 060213
  • 070213
  • 070413
  • 120413. 2) Instrumed Product Name: Replacement Screw Non-Springloaded
  • Trade Name: Boss Instruments
  • Boss Instruments Product Name: Replacement Screw Non-Springloaded for 74-0180
  • Boss Instruments Item Number: 74-0185
  • 120413. 3) Instrumed Product Name: Replacement Screw Non-Springloaded
  • Trade Name: Millennium Surgical
  • Millennium Surgical Product Name: Replacement Screw Non-Springloaded
  • Millennium Surgical Item Number: 6-1948
  • Lot Numbers: 020512

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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