Z-0541-2015 Class II Terminated
FDA device recall Z-0541-2015 was initiated by Instrumed International, Inc. on September 8, 2014 and is designated Class II. Reason for recall: The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements … The recall status is terminated (terminated November 29, 2017). Affected quantity: 1 Hudson cerebellar extension.
Recall Details
- Product Type
- Devices
- Report Date
- December 17, 2014
- Initiation Date
- September 8, 2014
- Termination Date
- November 29, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 Hudson cerebellar extension
Product Description
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.
Reason for Recall
The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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.
Distribution Pattern
Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.
Code Information
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.