The Recall Desk
ModerateFDA (Devices)·Z-0543-2015·Announced 2014-12-17

Instrumed Recalls Cushing Burr Instruments for Regulatory Non-Compliance

Instrumed International is withdrawing Cushing burrs because the company failed to meet FDA requirements for marketing pre-amendment devices.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is a voluntary withdrawal due to regulatory documentation and marketing compliance issues rather than a direct physical hazard or reported injury, fitting the criteria for moderate severity.

Plain-English summary

Instrumed International, Inc. is voluntarily withdrawing Cushing burrs from the market. These are bone cutting and drilling instruments used on a patient's skull without a power source. The devices were sold under the Medfix International and Stealth Surgical brand names.

The recall is due to regulatory non-compliance. Instrumed did not market these specific devices prior to September 26, 1976, and therefore does not meet all FDA requirements to market them as "Pre-Amendment" devices. The affected products include 3/8", 5/8", and 3/4" Cushing burrs with Lot Number 060311.

The devices were distributed nationwide, including in Arizona, California, Florida, Illinois, Kansas, Michigan, North Carolina, Ohio, Pennsylvania, Tennessee, Texas, and Virginia. No specific illnesses or injuries are reported in the source text. Healthcare providers and consumers should stop using these specific lot numbers and contact the manufacturer for instructions.

The recalled product

Product
Cushing burrs are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Medfix International and Stealth Surgical brand names.
Manufacturer
Instrumed International, Inc.
Category
Medical Device — Surgical Instruments
Hazard
Affected units
4

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: Cushing Burr
  • 3/8"
  • 10 mm
  • Instrumed Product Number: 600-00529
  • Trade Name: Medfix International
  • Medfix International Product Name: Cushing Burr
  • Medfix International Item Number: MF223-1592
  • Lot Number: 060311. 2) Instrumed Product Name: Cushing Burr
  • 5/8"
  • 16 mm
  • Instrumed Product Number: 600-00534
  • Medfix International Item Number: MF223-1597
  • Lot Number: 060311. 3) Instrumed Product Name: Cushing Burr
  • 3/4"
  • 20 mm
  • Instrumed Product Number: 600-00539
  • Trade Name: Stealth Surgical
  • Stealth Surgical Product Name: Cushing Burr
  • Stealth Surgical Item Number: SS2133
  • Lot Number: 060311.

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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