The Recall Desk
LowFDA (Devices)·Z-0540-2015·Announced 2014-12-17

Instrumed Recalls Hudson Braces for Regulatory Compliance Issues

Instrumed International is withdrawing Hudson braces from the market because the devices do not meet FDA requirements for pre-amendment status.

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 status issues rather than a physical defect or reported harm, fitting the criteria for Low severity.

Plain-English summary

Instrumed International, Inc. is voluntarily withdrawing Hudson braces 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 Teleflex Medical, Boss Instruments, Symmetry Surgical, and CareFusion brand names.

The recall is being conducted because 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. This is a regulatory compliance issue rather than a report of product malfunction or patient injury.

The affected products include eight Hudson braces distributed nationwide, including in Arizona, California, Florida, Illinois, Kansas, Michigan, North Carolina, Ohio, Pennsylvania, Tennessee, Texas, and Virginia. Specific lot numbers and item numbers for the affected units are listed in the agency's structured data. Consumers and healthcare providers should stop using these specific devices and contact the manufacturer for further instructions.

The recalled product

Product
Hudson braces are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Teleflex Medical, Boss Instruments, Symmetry Surgical, and CareFusion brand names.
Manufacturer
Instrumed International, Inc.
Category
Medical Device — Surgical Instruments
Hazard
Affected units
8

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 Brace
  • snap lock chuck
  • Instrumed Product Number: 600-00479
  • Trade Name: Telelfex Medical
  • Telelfex Medical Product Name: Hudson Brace
  • Telelfex Medical Item Number: P-22880
  • Lot Number: 110212. 2) Instrumed Product Name: Hudson Brace
  • Trade Name: Boss Instruments
  • Boss Instruments Product Name: Hudson Brace
  • Boss Instruments Item Number: 74-0121
  • Lot Number: 110212. 3) Instrumed Product Name: Hudson Brace Only
  • Instrumed Product Number: 600-00484
  • Trade Name: Symmetry Surgical
  • Symmetry Surgical Product Name: Hudson Brace Only
  • Symmetry Surgical Item Number: 57-6004
  • Lot Number: 060414. 4) Instrumed Product Name: Hudson Brace Only
  • Trade Name: Teleflex Medical
  • Teleflex Medical Product Name: Hudson Brace Only
  • Teleflex Medical Item Number: P-22881
  • Lot Number: 100211. 5) Instrumed Product Name: Hudson Brace Only

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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