The Recall Desk
LowFDA (Devices)·Z-0546-2015·Announced 2014-12-17

Instrumed Recalls D'errico Perforator Drills Due to Regulatory Non-Compliance

Instrumed International is withdrawing D'errico perforator drills 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 (failure to meet pre-amendment requirements) rather than a physical defect or reported health hazard, fitting the 'documentation issues' criterion for a Low severity score.

Plain-English summary

Instrumed International, Inc. is voluntarily withdrawing D'errico perforator 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 Symmetry Surgical, Teleflex Medical, 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 units are 16 mm D'errico Perforator Drills (Instrumed Product Number 600-00601). Specific lot numbers include 110211 for Symmetry Surgical and Teleflex Medical items. The devices were distributed nationwide, including in Arizona, California, Florida, Illinois, Kansas, Michigan, North Carolina, Ohio, Pennsylvania, Tennessee, Texas, and Virginia. Healthcare facilities should stop using these devices and contact the manufacturer for instructions.

The recalled product

Product
D'errico perforator drills are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Symmetry Surgical, Teleflex Medical, and CareFusion brand names.
Manufacturer
Instrumed International, Inc.
Category
Medical Device — Surgical Instruments
Hazard
Affected units
2

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 (14)

  • 1) Instrumed Product Name: D'errico Perforator Drill
  • 16 mm
  • Instrumed Product Number: 600-00601
  • Trade Name: Symmetry Surgical
  • Symmetry Surgical Product Name: D'errico Perforator Drill
  • Symmetry Surgical Item Number: 57-6076
  • Lot Number: 110211. 2) Instrumed Product Name: D'errico Perforator Drill
  • Trade Name: Teleflex Medical
  • Teleflex Medical Product Name: D'errico Perforator Drill
  • Teleflex Medical Item Number: P-22893
  • Lot Number: 110211. 3) Instrumed Product Name: D'errico Perforator Drill
  • Trade Name: CareFusion
  • CareFusion Product Name: D'errico Perforator Drill
  • CareFusion Item Number: VM85-1253.

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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