The Recall Desk
LowFDA (Devices)·Z-0556-2015·Announced 2014-12-17

Instrumed Recalls CVB Distraction Screws Due to Regulatory Non-Compliance

Instrumed International is withdrawing 790 CVB distraction screws because the devices were not marketed before 1976, failing 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 due to regulatory documentation and marketing compliance issues rather than a physical defect or safety hazard, which aligns with the 'Low' severity criteria for documentation issues.

Plain-English summary

Instrumed International, Inc. is voluntarily withdrawing 790 CVB distraction screws 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 various brand names, including Symmetry Surgical, Millennium Surgical, Medfix International, CareFusion, Boss Instruments, Medline Industries, Surgical Direct, and Teleflex Medical.

The reason for the withdrawal is that Instrumed did not market these devices prior to September 26, 1976. Consequently, the devices do not meet all FDA requirements to be marketed 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 CVB distraction screws and contact Instrumed International for further instructions. Consumers are not directly affected as these are professional medical instruments.

The recalled product

Product
CVB distraction screws are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Symmetry Surgical, Millennium Surgical, Medfix International, CareFusion, Boss Instruments, Medline Industries, Surgical Direct, and Telef
Manufacturer
Instrumed International, Inc.
Category
Medical Device — Surgical Instruments
Hazard
Affected units
790

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: CVB Distraction Screw
  • 12 mm
  • Non-Sterile
  • Instrumed Product Number: 650-11438
  • Trade Name: Symmetry Surgical
  • Symmetry Surgical Product Name: CVB Distraction Screw
  • Symmetry Surgical Item Number: 57-5106
  • Lot Number: 090109. 2) Instrumed Product Name: CVB Distraction Screw
  • Trade Name: Millennium Surgical
  • Millennium Surgical Product Name: CVB Distraction Screw
  • Millennium Surgical Item Number: 57-5106
  • Lot Number: 090109. 3) Instrumed Product Name: CVB Distraction Screw
  • Trade Name: Medfix International
  • Medfix International Product Name: CVB Distraction Screw
  • Medfix International Item Number: MF232-9052
  • Lot Numbers: 050214
  • 090109
  • 1290018. 4) Instrumed Product Name: CVB Distraction Screw
  • Trade Name: CareFusion
  • CareFusion Product Name: CVB Distraction Screw

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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