The Recall Desk
LowFDA (Devices)·Z-0548-2015·Announced 2014-12-17

Instrumed Recalls Hudson Cranial Drill Sets for Regulatory Non-Compliance

Instrumed International is withdrawing five Hudson cranial drill sets because the company failed to meet FDA requirements for marketing 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 a documentation and regulatory compliance issue regarding pre-amendment status rather than a physical defect or reported injury, fitting the criteria for a low-severity documentation issue.

Plain-English summary

Instrumed International, Inc. is voluntarily withdrawing five Hudson cranial drill sets 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, Stealth Surgical, and Boss Instruments brand names.

The recall is due to a regulatory compliance issue. Instrumed did not market these specific 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 are distributed nationwide, including in Arizona, California, Florida, Illinois, Kansas, Michigan, North Carolina, Ohio, Pennsylvania, Tennessee, Texas, and Virginia.

No specific consumer action is detailed in the source text beyond the withdrawal of the devices from the market. Healthcare facilities and distributors should verify their inventory against the specific lot numbers and item numbers provided in the recall notice to ensure these units are removed from use.

The recalled product

Product
Hudson cranial drill sets (w/ brace and 5 attachments) 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, Stealth Surgical, and Boss Instruments brand names.
Manufacturer
Instrumed International, Inc.
Category
Medical Device — Surgical Instruments
Hazard
Affected units
5

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 (12)

  • 1) Instrumed Product Name: Hudson Cranial Drill Set (w/ brace and 5 attachments)
  • Instrumed Product Number: 600-00616
  • Trade Name: Symmetry Surgical
  • Symmetry Surgical Item Number: 57-6000
  • Trade Name: Medfix International
  • Medfix International Item Number: MF223-1672
  • Trade Name: Stealth Surgical
  • Stealth Surgical Item Number: SS2135
  • Trade Name: Boss Instruments
  • Boss Instruments Item Number: 74-0120
  • Lot Numbers: 030112
  • 110212.

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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