The Recall Desk
LowFDA (Devices)·Z-0535-2015·Announced 2014-12-17

Instrumed Recalls Surgical Trocars Due to Regulatory Non-Compliance

Instrumed International is withdrawing 11 surgical trocars because they do 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 driven by regulatory documentation and marketing compliance issues rather than a direct physical hazard or reported injury, fitting the 'Low' severity criteria for documentation issues.

Plain-English summary

Instrumed International, Inc. is voluntarily withdrawing 11 surgical trocars from the market. These devices, sold under the Symmetry Surgical, CareFusion, and Ambler Surgical brand names, are sharp-pointed instruments used with a cannula to facilitate insertion into a vessel or chamber.

The recall is due to regulatory non-compliance. Instrumed did not market these devices prior to September 26, 1976, and therefore does not meet all FDA requirements to market them 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.

No specific health hazards or injuries are reported in the source text. The withdrawal is a regulatory action to ensure compliance with FDA marketing requirements for pre-amendment medical devices.

The recalled product

Product
A trocar is a sharp-pointed instrument used with a cannula for piercing a vessel or chamber to facilitate insertion of the cannula sold under the Symmetry Surgical, CareFusion, and Ambler Surgical brand names.
Manufacturer
Instrumed International, Inc.
Category
Medical Device — Surgical Instruments
Hazard
Affected units
11

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: Nelson Patterson Trocar
  • lg
  • 12 mm
  • Instrumed Product Number: 500-01938
  • Trade Name: Symmetry Surgical
  • Symmetry Surgical Product Name: Nelson Patterson Trocar
  • Symmetry Surgical Item Number: 54-7004
  • Lot Numbers: 050213
  • 100410. 2) Instrumed Product Name: Nelson Patterson Trocar
  • Trade Name: CareFusion
  • CareFusion Product Name: Nelson Patterson Trocar
  • CareFusion Item Number: VM72-3111
  • Lot Number: 050213. 3) Instrumed Product Name: Nelson Patterson Trocar
  • med-lg
  • 10 mm
  • Instrumed Product Number: 500-01943
  • Symmetry Surgical Item Number: 54-7005
  • Lot Number: 060312. 4) Instrumed Product Name: Nelson Patterson Trocar
  • Trade Name: Ambler Surgical
  • Ambler Surgical Product Name: Nelson Patterson Trocar

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.

See all →

Same hazard · regulatory non compliance

See all →