Model #CSS-QA-Adapter Lot #: GB759, GB-924, 1014001 & 1101011

Orthopedic Devices

1

No

Nationwide distribution: CA, CO, FL, GA, IL, KY, MD, MI, MO, MS, NC, NJ, NM, NY, OH, OR, PA, SD, TN, TX, VA, WA , and WI.

Quick Connect Adapter Model #CSS-QA-Adapter MaxTorque(R) Maxtorque Quick Connect Lot #s: 1014001 & 1101011, QTY 1 NON STERILE MAT:17-4PH || The intended use: Used to stabilize and aid in the fixation of fractures, fusions, and osteotomies.

All serial numbers prior to and including ACA5

Orthopedic Devices

2

No

Worldwide Distribution - USA including AL, AR, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, MA, MD, MI, MN, MO, MS, NC, NJ, NM, OH, PA, TN, TX, AND WA and the countries of Australia, Belgium, Canada, China, Denmark, Finland, France, Germany, Italy, Japan, Netherlands, Norway, South Africa, Spain, Sweden, Switzerland, Turkey, and the UK.

smith & nephew TRIGEN SURESHOT Distal Targeting System, Trauma Interface, V2.0.2, Trauma Launcher V1.01.1 || Product is intended to be an intraoperative image-guided localization system. It is a computer-assisted orthopedic surgery tool to aid the surgeon with drill positioning for screws during intramedullary nail implantation.

CSS-059-70-5, Modified 7.0 mm Modified Depth Gauge, Lot 0985031

Orthopedic Devices

1

No

Nationwide distribution: to the states of GA and MO.

CSS-059-70-5, Modified 7.0 mm Modified Depth Gauge, Lot 0985031

CSS-059-55-4, Modified 5.5 mm Modified Depth Gauge, Lot 0985021

Orthopedic Devices

1

No

Nationwide distribution: to the states of GA and MO.

CSS-059-55-4, Modified 5.5 mm Modified Depth Gauge, Lot 0985021

CSS-059-40-4 Modified 4.0mm Modified Depth Gauge, Lot 0985011

Orthopedic Devices

1

No

Nationwide distribution: to the states of GA and MO.

CSS-059-40-4 Modified 4.0mm Modified Depth Gauge, Lot 0985011

Lot #572H09 Use by 2012-06

Orthopedic Devices

Nationwide Distribution including Delaware, Massachusetts, Maryland, and New York

StaXx¿ XD Expandable Cartridge Convex Expandable Implant 25mm (L) x 9mm (W) x 7mm (H) || Catalog number: 11-1525 || The StaXx¿ XD System is a vertebral body replacement device intended for use in the thoracolumbar spine (TI-L5) to replace and restore height of a collapsed, damaged, or unstable vertebral body or portion thereof, due to tumor or trauma (i.e., fracture). The system is to be placed bilaterally and used with autograft or allograft and supplemental spinal fixation. The supplemental fixation system that is intended to be used with the StaXx¿ XD System is the CapSure¿ PS Spine System.

C44AJ4000, DG9K94000, DJ5EG4000, DJ5ER4000 and DJ5EW4000.

Orthopedic Devices

1

No

Worldwide distribution: USA including states of: AZ, AR, CA, CO, FL, GA, IA, ID,IL, IN, KY, KS, LA, MA, MD, MI, MN, NC, NV, PA, TN, TX, VA, WA, and WI; and countries including: Canada and Ireland. Australia, Austria, Canada, Denmark, Ireland, Israel Italy, New Zealand, Russia, Sweden, Switzerland, Spain, and UK.

S-ROM Distal Femoral Cutting block Guide SZ X- SM/SM, REF 216311001, non-sterile, Depuy International Leeds, England. || The product is used to make cuts in the femur to prepare the femur for total knee replacement surgery.

C44AK4000, D1WL94000, DG9LA4000, DJ5EF4000, DJ5EV4000, DY6GB4000 and DP5WM4000.

Orthopedic Devices

1

No

Worldwide distribution: USA including states of: AZ, AR, CA, CO, FL, GA, IA, ID,IL, IN, KY, KS, LA, MA, MD, MI, MN, NC, NV, PA, TN, TX, VA, WA, and WI; and countries including: Canada and Ireland. Australia, Austria, Canada, Denmark, Ireland, Israel Italy, New Zealand, Russia, Sweden, Switzerland, Spain, and UK.

S-ROM Distal Femoral Cutting block Guide SZ MED, REF 216311004, non-sterile, Depuy International Leeds, England. || The product is used to make cuts in the femur to prepare the femur for total knee replacement surgery.

1723336, 1768306, 2049011, ZB090424.

Orthopedic Devices

1

No

International distribution only: Netherlands, Germany, France, Spain, Italy and Denmark

Vanguard Knee Instruments offset reamer bushing - angled, REF 32-488519, Biomet Bridgend, UK. || This instrument is used to prepare the tibial cancellous bone for the tibial offset tray.

L75118

Orthopedic Devices

1

No

Nationwide Distribution including AL, AZ, CA, CO, FL, MI, MN, NC, PA, OH, OK, TN, TX, WA, and WI.

TiTLE 2 Polyaxial Spinal System, Counter Torque Assembly Tool, Part ET1132-01, Zimmer, Warsaw, IN. || The Zimmer Title 2 counter torque assembly tool is a reuseable, non- implantable surgical tool that is provided as part of a the device system for use as a secondary option for compression and distraction of the construct assembly and initial tightening of set screws. The instrument is designed to provide equal torque in the opposite direction to the torque that is being applied to the cap screw during tightening.

All lots of Part Number: 02.122.555S, 55mm Spiral Blade, 14mm, Right-Sterile

Orthopedic Devices

Nationwide Distribution including AL, CA, GA, IA, IL, IN, MA, MI, MS, NC, NJ, NV, OH, PA, SC, SD, TN, and WV.

02.122.555S, 55mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System || For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults.