Symmetry Surgical, Medfix International, CareFusion, Boss Instruments, Medline Industries

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.

Neurological Devices

2

No

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

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.