Hudson cerebellar extensions recalled for pre-amendment marketing status issues
Instrumed International is withdrawing Hudson cerebellar extensions because they were not marketed before September 26, 1976, and do not 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 due to a regulatory documentation and marketing status issue (failure to meet pre-amendment requirements) rather than a physical defect or reported injury, fitting the criteria for Low severity.
Plain-English summary
Instrumed International, Inc. is withdrawing Hudson cerebellar extensions from the market. These are bone cutting and drilling instruments used without a power source on a patient's skull, sold under the Boss Instruments brand name. The specific product affected is the Hudson Cerebellar Extension, with Instrumed Product Number 600-00499 and Lot Number 110411.
The reason for this withdrawal is that 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 regarding the device's marketing status rather than a reported defect or safety hazard.
The devices were distributed nationwide, including in Arizona, California, Florida, Illinois, Kansas, Michigan, North Carolina, Ohio, Pennsylvania, Tennessee, Texas, and Virginia. Consumers and healthcare providers should stop using these specific instruments and contact the recalling firm for further instructions.
The recalled product
- Product
- Hudson cerebellar extensions are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Boss Instruments brand name.
- Manufacturer
- Instrumed International, Inc.
- Affected units
- 1
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 (6)
- 1) Instrumed Product Name: Hudson Cerebellar Extension
- Instrumed Product Number: 600-00499
- Trade Name: Boss Industries
- Boss Industries Product Name: Hudson Cerebellar Extension
- Boss Industries Item Number: 74-0132
- Lot Number: 110411.
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.
See all 28 products in this recall →Related recalls
Same manufacturer · Instrumed International, Inc.
See all →- LowInstrumed Withdraws McKenzie Perforator Drills for Regulatory Compliance
FDA (Devices) · 2014-12-17
- LowInstrumed Withdraws McKenzie Enlarging Burrs Due to Regulatory Non-Compliance
FDA (Devices) · 2014-12-17
- LowInstrumed Recalls Cloward Spanner Gauges Due to Regulatory Non-Compliance
FDA (Devices) · 2014-12-17
- LowInstrumed Recalls Traction Tong Replacement Screws for Regulatory Compliance
FDA (Devices) · 2014-12-17
- LowInstrumed Recalls Schoitz Weights for Regulatory Compliance Issues
FDA (Devices) · 2014-12-17
Same hazard · regulatory non compliance
See all →- ModerateMedline 10mL Polycarbonate Colored Syringes in Convenience Kits Recalled
FDA (Devices) · 2026-07-01
- ModerateMedline 10mL Polycarbonate Colored Syringes Convenience Kits Recalled
FDA (Devices) · 2026-07-01
- SevereMedline 10mL Polycarbonate Syringes in Medical Procedure Kits Recalled
FDA (Devices) · 2026-07-01
- ModerateMedline Polycarbonate Syringes Recalled for Unapproved Design Changes
FDA (Devices) · 2026-07-01
- SevereMedline polycarbonate syringes recalled for unapproved design changes
FDA (Devices) · 2026-07-01