Home / Recalls / Instrumed International, Inc. / Z-0541-2015

Z-0541-2015 Class II Terminated

Recalled by Instrumed International, Inc. — Schaumburg, IL

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The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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.

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  • Z-0544-2015 Class II — Hudson burrs are bone cutting and drilling instruments that are used without a p (September 8, 2014)
  • Z-0534-2015 Class II — A zipser clamp is an instrument used to compress reduce blood flow to the penis (September 8, 2014)
  • Z-0538-2015 Class II — A circumcision clamp is an instrument used to compress the foreskin of the penis (September 8, 2014)
  • Z-0549-2015 Class II — Galt trephines are bone cutting and drilling instruments that are used without a (September 8, 2014)
  • Z-0535-2015 Class II — A trocar is a sharp-pointed instrument used with a cannula for piercing a vessel (September 8, 2014)
  • Z-0536-2015 Class II — An external vein stripper is an extravascular device used to remove a section of (September 8, 2014)