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U.S. Department of Health and Human Services

Class 2 Device Recall Boss Instruments

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  Class 2 Device Recall Boss Instruments see related information
Date Initiated by Firm September 08, 2014
Date Posted December 16, 2014
Recall Status1 Terminated 3 on November 29, 2017
Recall Number Z-0541-2015
Recall Event ID 69471
Product Classification Drills, burrs, trephines & accessories (manual) - Product Code HBG
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.
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.
Recalling Firm/
Instrumed International, Inc.
626 Cooper Ct
Schaumburg IL 60173-4537
For Additional Information Contact Ms. Jennifer S. Staunton
Manufacturer 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The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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.
FDA Determined
Cause 2
No Marketing Application
Action Instrumed sent an URGENT: MEDICAL DEVICE MARKET WITHDRAWAL letters dated October 9, 2014 to all affected customers. The letter included instructions for customers to: 1) examine their inventory to determine if there are any recalled devices; 2) complete and return the enclosed Confirmation Request Form; 3) return the recalled devices; and 4) share the recall information with facility staff. Customers with questions were instructed to contact Instrumed by telephone at 847-908-6119.
Quantity in Commerce 1 Hudson cerebellar extension
Distribution Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.