The Recall Desk
LowFDA (Devices)·Z-0544-2015·Announced 2014-12-17

Instrumed Recalls Hudson Burrs for Pre-Amendment Regulatory Non-Compliance

Instrumed International is withdrawing 16 Hudson burrs from the market because the company did not market these devices prior to September 26, 1976, and therefore does 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 due to regulatory non-compliance regarding the marketing date of the devices, not a physical defect or safety hazard. The source text does not report any illnesses, injuries, or deaths, and the hazard is administrative rather than physical.

Plain-English summary

Instrumed International, Inc. is voluntarily withdrawing 16 Hudson burrs from the market. These bone cutting and drilling instruments are used without a power source on a patient's skull and were sold under the Symmetry Surgical, Medfix International, CareFusion, Boss Instruments, and Medline Industries brand names.

The reason for this withdrawal is that Instrumed did not market these devices prior to September 26, 1976. Consequently, the company does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. The affected products were distributed nationwide, including in Arizona, California, Florida, Illinois, Kansas, Michigan, North Carolina, Ohio, Pennsylvania, Tennessee, Texas, and Virginia.

The source text does not specify any reported illnesses, injuries, or deaths associated with these devices. Consumers and healthcare facilities should check their inventory for the specific Hudson burrs listed in the recall notice and contact Instrumed International for further instructions on the withdrawal.

The recalled product

Product
Hudson burrs are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Symmetry Surgical, Medfix International, CareFusion, Boss Instruments, and Medline Industries brand names.
Manufacturer
Instrumed International, Inc.
Category
Medical Device — Surgical Instruments
Hazard
Affected units
16

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: Hudson Burr
  • 9 mm
  • Instrumed Product Number: 600-00549
  • Trade Name: Symmetry Surgical
  • Symmetry Surgical Product Name: Hudson Burr
  • Symmetry Surgical Item Number: 57-6009
  • Lot Number: 030211. 2) Instrumed Product Name: Hudson Burr
  • Trade Name: Medfix International
  • Medfix International Product Name: Hudson Burr
  • Medfix International Item Number: MF223-1612
  • Lot Number: 060410. 3) Instrumed Product Name: Hudson Burr
  • Trade Name: CareFusion
  • CareFusion Product Name: Hudson Burr
  • CareFusion Item Number: VM85-1235
  • Lot Number: 030211. 4) Instrumed Product Name: Hudson Burr
  • Trade Name: Boss Instruments
  • Boss Instruments Product Name: Hudson Burr
  • Boss Instruments Item Number: 74-0124
  • Lot Number: 060410. 5) Instrumed Product Name: Hudson Burr
  • 10 mm

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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Same hazard · regulatory non compliance

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