Symmetry Surgical, Millennium Surgical, Medfix International, CareFusion, Boss Instruments, etc.

1) Instrumed Product Name: CVB Distraction Screw, 12 mm, Non-Sterile; Instrumed Product Number: 650-11438; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: CVB Distraction Screw, 12 mm, Non-Sterile; Symmetry Surgical Item Number: 57-5106; Lot Number: 090109.   2) Instrumed Product Name: CVB Distraction Screw, 12 mm, Non-Sterile; Instrumed Product Number: 650-11438; Trade Name: Millennium Surgical; Millennium Surgical Product Name: CVB Distraction Screw, 12 mm, Non-Sterile; Millennium Surgical Item Number: 57-5106; Lot Number: 090109.   3) Instrumed Product Name: CVB Distraction Screw, 12 mm, Non-Sterile; Instrumed Product Number: 650-11438; Trade Name: Medfix International; Medfix International Product Name: CVB Distraction Screw, 12 mm, Non-Sterile; Medfix International Item Number: MF232-9052; Lot Numbers: 050214, 090109, 1290018.   4) Instrumed Product Name: CVB Distraction Screw, 12 mm, Non-Sterile; Instrumed Product Number: 650-11438; Trade Name: CareFusion; CareFusion Product Name: CVB Distraction Screw, 12 mm, Non-Sterile; CareFusion Item Number: VM84-3602; Lot Numbers: 090109.   5) Instrumed Product Name: CVB Distraction Screw, 12 mm, Non-Sterile; Instrumed Product Number: 650-11438; Trade Name: Boss Instruments; Boss Instruments Product Name: CVB Distraction Screw, pkg 5, 12 mm, Non-Sterile; Boss Instruments Item Number: 73-2591; Lot Numbers: 090109.   6) Instrumed Product Name: CVB Distraction Screw, 14 mm, Non-Sterile; Instrumed Product Number: 650-11454; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: CVB Distraction Screw, 14 mm, Non-Sterile; Symmetry Surgical Item Number: 57-5107; Lot Numbers: 020313, 090209.   7) Instrumed Product Name: CVB Distraction Screw, 14 mm, Non-Sterile; Instrumed Product Number: 650-11454; Trade Name: Millennium Surgical; Millennium Surgical Product Name: CVB Distraction Screw, 14 mm, Non-Sterile; Millennium Surgical Item Number: 6-2878; Lot Numbers: 070109, 090109, 090209.   8) Instrumed Product Name: CVB Distraction Screw, 14 mm, Non-Sterile; Instrumed Product Number: 650-11454; Trade Name: Medline Industries; Medline Industries Product Name: CVB Distraction Screw, 14 mm, Non-Sterile; Medline Industries Item Number: MDG1108066; Lot Numbers: 020313, 090209.   9) Instrumed Product Name: CVB Distraction Screw, 14 mm, Non-Sterile; Instrumed Product Number: 650-11454; Trade Name: Medfix International; Medfix International Product Name: CVB Distraction Screw, 14 mm, Non-Sterile; Medfix International Item Number: MF232-9057; Lot Numbers: 020313, 050214, 090209.   10) Instrumed Product Name: CVB Distraction Screw, 14 mm, Non-Sterile; Instrumed Product Number: 650-11454; Trade Name: Surgical Direct; Surgical Direct Product Name: CVB Distraction Screw, 14 mm, Non-Sterile; Surgical Direct Item Number: SD145691.103; Lot Number: 090209.   11) Instrumed Product Name: CVB Distraction Screw, 14 mm, Non-Sterile; Instrumed Product Number: 650-11454; Trade Name: CareFusion; CareFusion Product Name: CVB Distraction Screw, 14 mm, Non-Sterile; CareFusion Item Number: VM84-3603; Lot Numbers: 020313, 090209.   12) Instrumed Product Name: CVB Distraction Screw, 14 mm, Non-Sterile; Instrumed Product Number: 650-11454; Trade Name: Teleflex Medical; Teleflex Medical Product Name: Distraction Screw CVD 14 mm; Teleflex Medical Item Number: P-22488; Lot Number: 090209.   13) Instrumed Product Name: CVB Distraction Screw, 16 mm, Non-Sterile; Instrumed Product Number: 650-11470; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: CVB Distraction Screw, 16 mm, Non-Sterile; Symmetry Surgical Item Number: 57-5108; Lot Numbers: 010114, 120408.   14) Instrumed Product Name: CVB Distraction Screw, 16 mm, Non-Sterile; Instrumed Product Number: 650-11470; Trade Name: Millennium Surgical; Millennium Surgical Product Name: CVB Distraction Screw, 16 mm, Non-Sterile; Millennium Surgical Item Number: 6-2879; Lot Number: 120408.   15) Instrumed Product Name: CVB Distraction Screw, 16 mm, Non-Sterile; Instrumed Product Number: 650-11470; Trade Name: Medfix International; Medfix International Product Name: CVB Distraction Screw, 16 mm, Non-Sterile; Medfix International Item Number: MF232-9062; Lot Number: 120408.   16) Instrumed Product Name: CVB Distraction Screw, 16 mm, Non-Sterile; Instrumed Product Number: 650-11470; Trade Name: CareFusion; CareFusion Product Name: CVB Distraction Screw, 16 mm, Non-Sterile; CareFusion Item Number: VM84-3604; Lot Number: 120408.   17) Instrumed Product Name: CVB Distraction Screw, 18 mm, Non-Sterile; Instrumed Product Number: 650-11486; Trade Name: Symmetry Surgical; Symmetry SurgicalProduct Name: CVB Distraction Screw, 18 mm, Non-Sterile; Symmetry SurgicalItem Number: 57-5100; Lot Numbers: 040109, 121610.

Neurological Devices

2

No

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

CVB distraction screws are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Symmetry Surgical, Millennium Surgical, Medfix International, CareFusion, Boss Instruments, Medline Industries, Surgical Direct, and Teleflex Medical brand names.