Hudson cerebellar extensions are bone cutting and recall
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…
Why was Hudson cerebellar extensions are bone cutting and recalled?
The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- 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…
- Recalling firm
- Instrumed International, Inc.
- Quantity
- 1 Hudson cerebellar extension
- Distribution
- Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.
- Recall date
- December 17, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)