The Recall Desk
LowFDA (Devices)·Z-0554-2015·Announced 2014-12-17

Instrumed Recalls Traction Tong Replacement Screws for Regulatory Compliance

Instrumed International is withdrawing 17 traction tong replacement screws because they do not meet FDA requirements for pre-amendment devices.

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 issues regarding pre-amendment device status rather than a reported safety hazard, injury, or defect, which aligns with the 'Low' severity criteria for documentation or regulatory issues.

Plain-English summary

Instrumed International, Inc. is withdrawing 17 traction tong replacement screws, non-springloaded, from the market. These devices are used in traction skull tongs to immobilize patients with cervical spine injuries and are sold under the CareFusion, Boss Instruments, and Stealth Surgical brand names.

The withdrawal is occurring because 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. The affected units were distributed nationwide, including in Arizona, California, Florida, Illinois, Kansas, Michigan, North Carolina, Ohio, Pennsylvania, Tennessee, Texas, and Virginia.

Healthcare facilities and distributors should stop using these specific devices and contact Instrumed International for further instructions. The recall involves specific lot numbers and item numbers for the CareFusion, Boss Instruments, and Stealth Surgical brands.

The recalled product

Product
Traction tong replacement screws, non-springloaded 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, Boss Instruments, and Stealth Surgical brand names.
Manufacturer
Instrumed International, Inc.
Category
Medical Device — Orthopedic / Spinal
Hazard
Affected units
17

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 (19)

  • 1) Instrumed Product Name: Replacement Screw Non-Springloaded
  • Traction Tong
  • Instrumed Product Number: 638-05429
  • Trade Name: CareFusion
  • CareFusion Product Name: Gardner-Wells Titanium Fixation Screw Non-Springloaded
  • CareFusion Item Number: NL9514-T
  • Trade Name: Boss Instruments
  • Boss Instruments Product Name: Replacement Screw Non-Springloaded
  • Boss Instruments Item Number: 74-0185T
  • Lot Numbers: 020512
  • 100512
  • 110211. 3) Instrumed Product Name: Replacement Screw Non-Springloaded
  • Trade Name: Stealth Surgical
  • Stealth Surgical Product Name: Replacement Screw Non-Springloaded
  • Stealth Surgical Item Number: SS2193BT
  • CareFusion Product Name: Replacement Screw Non-Springloaded
  • CareFusion Item Number: VM85-12965
  • Lot Numbers: 100512
  • 110211.

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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