Instrumed International, Inc.: Medical Device Recall in 2014 - (Recall #: Z-0544-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

Hudson burrs are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Symmetry Surgical, Medfix International, CareFusion, Boss Instruments, and Medline Industries brand names.

Product Classification:

Class II

Date Initiated: September 8, 2014

Date Posted: December 17, 2014

Recall Number: Z-0544-2015

Event ID: 69471

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The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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

Status: Terminated

Product Quantity: 16 Hudson burrs

Code Information:

1) Instrumed Product Name: Hudson Burr, 9 mm; Instrumed Product Number: 600-00549; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Hudson Burr, 9 mm; Symmetry Surgical Item Number: 57-6009; Lot Number: 030211. 2) Instrumed Product Name: Hudson Burr, 9 mm; Instrumed Product Number: 600-00549; Trade Name: Medfix International; Medfix International Product Name: Hudson Burr, 9 mm; Medfix International Item Number: MF223-1612; Lot Number: 060410. 3) Instrumed Product Name: Hudson Burr, 9 mm; Instrumed Product Number: 600-00549; Trade Name: CareFusion; CareFusion Product Name: Hudson Burr, 9 mm; CareFusion Item Number: VM85-1235; Lot Number: 030211. 4) Instrumed Product Name: Hudson Burr, 9 mm; Instrumed Product Number: 600-00549; Trade Name: Boss Instruments; Boss Instruments Product Name: Hudson Burr, 9 mm; Boss Instruments Item Number: 74-0124; Lot Number: 060410. 5) Instrumed Product Name: Hudson Burr, 10 mm; Instrumed Product Number: 600-00553; Trade Name: Boss Instruments; Boss Instruments Product Name: Hudson Burr, 10 mm; Boss Instruments Item Number: 74-0125; Lot Number: 030305. 6) Instrumed Product Name: Hudson Burr, 14 mm; Instrumed Product Number: 600-00561; Trade Name: CareFusion; CareFusion Product Name: Hudson Burr, 14 mm; CareFusion Item Number: H-0343; Lot Numbers: 110212, 120313. 7) Instrumed Product Name: Hudson Burr, 14 mm; Instrumed Product Number: 600-00561; Trade Name: Medline Industries; Medline Industries Product Name: Hudson Burr, 14 mm; Medline Industries Item Number: MDG1199404; Lot Number: 030213. 8) Instrumed Product Name: Hudson Burr, 14 mm; Instrumed Product Number: 600-00561; Trade Name: Boss Instruments; Boss Instruments Product Name: Hudson Burr, 14 mm; Boss Instruments Item Number: 74-0126; Lot Number: 120313. 9) Instrumed Product Name: Hudson Burr, 16 mm; Instrumed Product Number: 600-00566; Trade Name: Boss Instruments; Boss Instruments Product Name: Hudson Burr, 16 mm; Boss Instruments Item Number: 74-0128; Lot Number: 110111. 10) Instrumed Product Name: Hudson Burr, 22 mm; Instrumed Product Number: 600-00571; Trade Name: CareFusion; CareFusion Product Name: Hudson Burr, 22 mm; CareFusion Item Number: VM85-1241; Lot Number: 110212. 11) Instrumed Product Name: Hudson Burr, 22 mm; Instrumed Product Number: 600-00571; Trade Name: Boss Instruments; Boss Instruments Product Name: Hudson Burr, 22 mm; Boss Instruments Item Number: 74-0130; Lot Number: 110212. 12) Instrumed Product Name: Hudson Burr, 16 mm; Instrumed Product Number: 606-00566; Trade Name: CareFusion; CareFusion Product Name: Hudson Burr, 16 mm; CareFusion Item Number: VM85-12391; Lot Number: 050108.

Distribution Pattern:

Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.

Voluntary or Mandated:

Voluntary: Firm initiated