The Recall Desk
LowFDA (Devices)·Z-0545-2015·Announced 2014-12-17

Instrumed Withdraws McKenzie Perforator Drills for Regulatory Compliance

Instrumed International is withdrawing McKenzie Perforator Drills because the company did not market them before September 26, 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 rather than a physical defect or reported health hazard, fitting the criteria for Low severity.

Plain-English summary

Instrumed International, Inc. is withdrawing four McKenzie Perforator Drills from the market. These are bone cutting and drilling instruments used without a power source on a patient's skull. The devices were sold under the Phoenix Instruments, Stealth Surgical, CareFusion, and Boss Instruments brand names.

The withdrawal is due to regulatory compliance issues. 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. Specific lot numbers and product identifiers are listed in the official recall record.

The recalled product

Product
McKenzie Perforator Drills are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Phoenix Instruments, Stealth Surgical, CareFusion, and Boss Instruments 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: McKenzie Perforator Drill
  • 13 mm
  • Instrumed Product Number: 600-00591
  • Trade Name: Phoenix Instruments
  • Phoenix Instruments Product Name: McKenzie Perforator Drill
  • Phoenix Instruments Item Number: 157-6043
  • Lot Number: 070412. 2) Instrumed Product Name: McKenzie Perforator Drill
  • Trade Name: Stealth Surgical
  • Stealth Surgical Product Name: McKenzie Perforator Drill
  • Stealth Surgical Item Number: SS2151
  • Lot Number: 070412. 3) Instrumed Product Name: McKenzie Perforator Drill
  • Trade Name: CareFusion
  • CareFusion Product Name: McKenzie Perforator Drill
  • CareFusion Item Number: VM85-1235
  • Lot Number: 030211. 4) Instrumed Product Name: McKenzie Perforator Drill
  • CareFusion Item Number: VM85-1251
  • Lot Number: 050111. 5) Instrumed Product Name: McKenzie Perforator Drill
  • Trade Name: Boss Instruments
  • Boss Instruments Product Name: McKenzie Perforator Drill
  • Boss Instruments Item Number: 74-0140

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 →

Related recalls

Same manufacturer · Instrumed International, Inc.

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Same hazard · regulatory non compliance

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