The Recall Desk
LowFDA (Devices)·Z-0542-2015·Announced 2014-12-17

Instrumed Recalls Cushing Perforating Drills for Regulatory Non-Compliance

Instrumed International is withdrawing nine Cushing perforating 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 patient injury, fitting the criteria for a low-severity documentation issue.

Plain-English summary

Instrumed International, Inc. is voluntarily withdrawing nine Cushing perforating 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 Boss Instruments, Symmetry Surgical, Medfix International, Stealth Surgical, and CareFusion brand names.

The recall was initiated because Instrumed did not market these specific 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 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 the affected drills and contact Instrumed International for further instructions. The specific lot numbers and product identifiers for the nine affected units are detailed in the official FDA recall notice Z-0542-2015.

The recalled product

Product
Cushing perforating drills are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Boss Instruments, Symmetry Surgical, Medfix International, Stealth Surgical, and CareFusion brand names.
Manufacturer
Instrumed International, Inc.
Category
Medical Device — Surgical Instruments
Hazard
Affected units
9

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 Perforating
  • Drill
  • 3/8"
  • 10 mm
  • Instrumed Product Number: 600-00509
  • Trade Name: Boss Industries
  • Boss Industries Product Name: Cushing Perforating
  • Boss Industries Item Number: 74-0100
  • Lot Number: 110211. 2) Instrumed Product Name: Cushing Perforating
  • 1/2"
  • 13 mm
  • Instrumed Product Number: 600-00514
  • Trade Name: Symmetry Surgical
  • Symmetry Surgical Product Name: Cushing Perforating
  • Symmetry Surgical Item Number: 57-6034
  • Lot Number: 060212. 3) Instrumed Product Name: Cushing Perforating
  • Trade Name: Medfix International
  • Medfix International Product Name: Cushing Perforating
  • Medfix International Item Number: MF223-1577
  • Lot Number: 060212. 4) Instrumed Product Name: Cushing Perforating

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 manufacturer · Instrumed International, Inc.

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Same hazard · regulatory non compliance

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