Instrumed Recalls Manual Bunnell Cranial Drills for Regulatory Non-Compliance
Instrumed International is withdrawing 13 manual Bunnell cranial drills because the company did not market them 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 driven by a regulatory documentation and marketing compliance issue (failure to meet pre-amendment status) rather than a physical defect or reported injury, fitting the criteria for a Low severity documentation issue.
Plain-English summary
Instrumed International, Inc. is withdrawing 13 manual Bunnell cranial drills from the market. These bone cutting and drilling instruments, sold under the Boss Instruments brand, are used without a power source on a patient's skull. The specific items involved are the Bunnell Drill, 5 3/4", with chuck key (Instrumed Product Number 590-05389; Boss Instruments Item Number 74-1240), with lot numbers 030511, 060110, and 070311.
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. This is a regulatory compliance issue rather than a report of device malfunction or patient injury.
The affected drills 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 these specific instruments and contact Instrumed International for further instructions on the withdrawal.
The recalled product
- Product
- Manual bunnell cranial drills are bone cutting and drilling instruments that are used without a power source on a patient's skull sold under the Boss Instruments brand name.
- Manufacturer
- Instrumed International, Inc.
- Affected units
- 13
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: Bunnell Drill
- 5 3/4"
- w/ chuck key
- Instrumed Product Number: 590-05389
- Trade Name: Boss Instruments
- Boss Instruments Product Name: Bunnell Drill
- Boss Instruments Item Number: 74-1240
- Lot Numbers: 030511
- 060110
- 070311.
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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