Instrumed Withdraws McKenzie Enlarging Burrs Due to Regulatory Non-Compliance
Instrumed International is withdrawing McKenzie enlarging burrs because the company did not market them prior to 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 health hazard, fitting the criteria for a low-severity documentation issue.
Plain-English summary
Instrumed International, Inc. is withdrawing McKenzie enlarging burrs 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 CareFusion and Boss Instruments brand names.
The reason for this withdrawal is that Instrumed did not market these 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 products include 3 McKenzie enlarging burrs distributed nationwide, including in Arizona, California, Florida, Illinois, Kansas, Michigan, North Carolina, Ohio, Pennsylvania, Tennessee, Texas, and Virginia. Specific lot numbers 030411 and 060311 are identified in the recall notice. Consumers and healthcare providers should stop using these devices and contact the manufacturer for further instructions.
The recalled product
- Product
- McKenzie enlarging burrs are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the CareFusion and Boss Instruments brand names.
- Manufacturer
- Instrumed International, Inc.
- Affected units
- 3
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 (10)
- 1) Instrumed Product Name: McKenzie Enlarging Burr
- Instrumed Product Number: 600-00606
- Trade Name: CareFusion
- CareFusion Product Name: McKenzie Enlarging Burr
- CareFusion Item Number: VM85-1255
- Lot Number: 030411. 2) Instrumed Product Name: McKenzie Enlarging Burr
- Trade Name: Boss Instruments
- Boss Instruments Product Name: McKenzie Enlarging Burr
- Boss InstrumentsItem Number: 74-0144
- Lot Number: 060311.
Distribution
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.
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