ALL LOTS to include: NM04H0021, NM04H0051, NM04H005Z, NM04H0321

Orthopedic Devices

1

No

Nationwide

Medtronic Sofamor Danek, 8 mm Trial, size 8 mm, Material Stainless Steel/Radel, quantity 1 each, Non-sterile, Rx only, REF 8004208, Manufactured at: Bartlett, Tennessee, USA

Lot 013886.

Orthopedic Devices

1

No

Nationwide: including states of California, Florida, Michigan and North Carolina.

Pioneer Quantum Spinal Rod System, MIS Yoke Manipulator, Long Slot, non-sterile; Cat # 51-YOKEMAN-L, Pioneer Surgical Technology, Marquette, MI 49855

Lots 095112 and 474660.

Orthopedic Devices

1

No

Nationwide; including states of Alabama, Arizona, Arkansas, Georgia, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Nevada, North Carolina, Ohio and South Dakota.

Biomet Straight Magnum Inserter Handle, a preparatory instrument used for acetabular component insertion; REF # or Catalog Number: S313141. (systems affected by this action include M2a-Magnum, Regenerex, Acetabular Revision Shell and M2a-38), Biomet Orthopedics, Inc., Warsaw, IN. 46581

Lot Number: 038670.

Orthopedic Devices

1

No

Worldwide-USA, Germany, The Netherlands, Sweden and The United Kingdom.

Biomet RINGLOC + Instrumentation Impactor Plate, Size 20; REF/Part #: 31-400620, Biomet Orthopedics, Inc., Warsaw, IN.

Lot Number: 038680.

Orthopedic Devices

1

No

Worldwide-USA, Germany, The Netherlands, Sweden and The United Kingdom.

Biomet RINGLOC + Instrumentation Impactor Plate, Size 21; REF 31-400621,Biomet Orthopedics, Inc., Warsaw, IN.

Lot Number: 038690.

Orthopedic Devices

1

No

Worldwide-USA, Germany, The Netherlands, Sweden and The United Kingdom.

Biomet RINGLOC + Instrumentation Impactor Plate, Size 22; REF/Part#: 31-400622, Biomet Orthopedics, Inc., Warsaw, IN.

Lot Number: 038700.

Orthopedic Devices

1

No

Worldwide-USA, Germany, The Netherlands, Sweden and The United Kingdom.

Biomet RINGLOC + Instrumentation Impactor Plate, Size 23; REF/Part#: 31-400623, Biomet Orthopedics, Inc., Warsaw, IN.

Lot Number: 038710.

Orthopedic Devices

1

No

Worldwide-USA, Germany, The Netherlands, Sweden and The United Kingdom.

Biomet RINGLOC + Instrumentation Impactor Plate, Size 26; REF/Part#: 31-400626, Biomet Orthopedics, Inc., Warsaw, IN.

Lot Number: 038730.

Orthopedic Devices

1

No

Worldwide-USA, Germany, The Netherlands, Sweden and The United Kingdom.

Biomet RINGLOC + Instrumentation Impactor Plate, Size 28; REF/Part#: 31-400628, Biomet Orthopedics, Inc., Warsaw, IN.

Serial number 723505023 through 804326503.

Orthopedic Devices

1

No

Worldwide Distribution including USA and countries of Australia, Brazil, Canada, Chile, Colombia, Costa Rica, England, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Malaysia, Netherlands, New Zealand, Pakistan, Panama, Peru, Philippines, Poland, Romania, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan and Turkey.

Stryker Cordless Driver 3 Handpiece. Stryker Instruments, Kalamazoo, MI; REF 4300. || The device is intended for use in surgical procedures involving drilling, reaming, driving wire or pins, and cutting bone and hard tissue.

Serial numbers 0614504853 through 0825902483.

Orthopedic Devices

1

No

Worldwide Distribution including USA and countries of Australia, Brazil, Canada, Chile, Colombia, Costa Rica, England, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Malaysia, Netherlands, New Zealand, Pakistan, Panama, Peru, Philippines, Poland, Romania, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan and Turkey.

Stryker Rotary Handpiece, Single Trigger, For use with Stryker System 6. Stryker Instruments, Kalamazoo, MI; REF 6203. || The device is intended for use in surgical procedures involving drilling, reaming, driving wire or pins, and cutting bone and hard tissue.

Serial numbers 0817003173 through 0825905983.

Orthopedic Devices

1

No

Worldwide Distribution including USA and countries of Australia, Brazil, Canada, Chile, Colombia, Costa Rica, England, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Malaysia, Netherlands, New Zealand, Pakistan, Panama, Peru, Philippines, Poland, Romania, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan and Turkey.

Stryker Rotary Handpiece, Single Trigger, For use with Stryker System 6. Stryker Instruments, Kalamazoo, MI; REF 6203-000-000S1. || The device is intended for use in surgical procedures involving drilling, reaming, driving wire or pins, and cutting bone and hard tissue.

Serial numbers 0615001103 through 0826001573.

Orthopedic Devices

1

No

Worldwide Distribution including USA and countries of Australia, Brazil, Canada, Chile, Colombia, Costa Rica, England, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Malaysia, Netherlands, New Zealand, Pakistan, Panama, Peru, Philippines, Poland, Romania, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan and Turkey.

Stryker Rotary Handpiece, Dual Trigger, For use with Stryker System 6. Stryker Instruments, Kalamazoo, MI; REF 6205. || The device is intended for use in surgical procedures involving drilling, reaming, driving wire or pins, and cutting bone and hard tissue.

Serial numbers 0807117993 through 0811212433.

Orthopedic Devices

1

No

Worldwide Distribution including USA and countries of Australia, Brazil, Canada, Chile, Colombia, Costa Rica, England, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Malaysia, Netherlands, New Zealand, Pakistan, Panama, Peru, Philippines, Poland, Romania, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan and Turkey.

Stryker Rotary Handpiece, Dual Trigger, For use with Stryker System 6. Stryker Instruments, Kalamazoo, MI; REF 6205-000-000S1. || The device is intended for use in surgical procedures involving drilling, reaming, driving wire or pins, and cutting bone and hard tissue.

Serial numbers 0613702313 through 0826201253.

Orthopedic Devices

1

No

Worldwide Distribution including USA and countries of Australia, Brazil, Canada, Chile, Colombia, Costa Rica, England, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Malaysia, Netherlands, New Zealand, Pakistan, Panama, Peru, Philippines, Poland, Romania, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan and Turkey.

Stryker Reciprocating Saw, For use with Stryker System 6. Stryker Instruments, Kalamazoo, MI; REF 6206. || Product is a linear cutting device used for cutting bone and bone related tissue.

Serial numbers 0613902933 through 0826101223.

Orthopedic Devices

1

No

Worldwide Distribution including USA and countries of Australia, Brazil, Canada, Chile, Colombia, Costa Rica, England, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Malaysia, Netherlands, New Zealand, Pakistan, Panama, Peru, Philippines, Poland, Romania, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan and Turkey.

Stryker Sternum Saw, For use with Stryker System 6. Stryker Instruments, Kalamazoo, MI; REF 6207. || The product is a linear cutting device used for cutting bone and bone related tissue including the sternum.

Serial numbers 0615000953 through 0826200893.

Orthopedic Devices

1

No

Worldwide Distribution including USA and countries of Australia, Brazil, Canada, Chile, Colombia, Costa Rica, England, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Malaysia, Netherlands, New Zealand, Pakistan, Panama, Peru, Philippines, Poland, Romania, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan and Turkey.

Stryker Sagittal Saw, For use with Stryker System 6. Stryker Instruments, Kalamazoo, MI; REF 6208. Note: The product label declares the product to be a handpiece. || The product is an oscillating cutting device used for cutting bone and bone related tissue.

Serial numbers 0801802893 through 0801802913.

Orthopedic Devices

1

No

Worldwide Distribution including USA and countries of Australia, Brazil, Canada, Chile, Colombia, Costa Rica, England, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Malaysia, Netherlands, New Zealand, Pakistan, Panama, Peru, Philippines, Poland, Romania, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan and Turkey.

Stryker Sagittal Saw, For use with Stryker System 6. Stryker Instruments, Kalamazoo, MI; REF 6208-000-000S4. || The product is an oscillating cutting device used for cutting bone and bone related tissue.

Serial numbers 0620602123 through 0825317713.

Orthopedic Devices

1

No

Worldwide Distribution including USA and countries of Australia, Brazil, Canada, Chile, Colombia, Costa Rica, England, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Malaysia, Netherlands, New Zealand, Pakistan, Panama, Peru, Philippines, Poland, Romania, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan and Turkey.

Stryker Precision Oscillating Tip Saw, For use with Stryker System 6. Stryker Instruments, Kalamazoo, MI; REF 6209. || The product is an oscillating cutting device used for cutting bone and bone related tissue.

lot code 326081; and lot code 327081.

Orthopedic Devices

1

No

Nationwide Distribution

Integra Ruggles Surgical Instrument ACF Distraction Screws || Sterile, Rx only || Catalog number R6357A (12 mm), Catalog number R6397A (16 mm), || Integra LifeSciences Corp., 311 Enterprise Drive, Plainsboro, NJ 08536

Lot Number 50278012.

Orthopedic Devices

1

No

Worldwide Distribution -- United States including Puerto Rico, Australia, Austria, Belgium, Canada, Costa Rica, Dubai, Finland, France, Germany, Great Britain, Netherlands, Norway, Portugal, Spain, Sweden, and Switzerland.

AlMER ENDOFEMORAL 4MM OFFSET (PURPLE) || Part Number 72201714. || The product is an orthopedic device.

Lot # N64648, 6082633, and 6107223.

Orthopedic Devices

1

No

Nationwide Distribution -- State of CA.

SYNTHES 2.0MM DRILL BIT STRYKER J-LATCH/60MM, Catalog # 317.853. || Synthes Titanium Matrix Mandible Sagittal Plates and Instruments are intended for general use in orthognathic surgery.

Lot Number 502780141

Orthopedic Devices

1

No

Worldwide Distribution -- United States including Puerto Rico, Australia, Austria, Belgium, Canada, Costa Rica, Dubai, Finland, France, Germany, Great Britain, Netherlands, Norway, Portugal, Spain, Sweden, and Switzerland.

AIMER ENDOFEMORAL 6MM OFFSET (GREEN) Part Number 72201716. || The product is an orthopedic device.

Lot Number 50278014.

Orthopedic Devices

1

No

Worldwide Distribution -- United States including Puerto Rico, Australia, Austria, Belgium, Canada, Costa Rica, Dubai, Finland, France, Germany, Great Britain, Netherlands, Norway, Portugal, Spain, Sweden, and Switzerland.

AIMER ENDOFEMORAL 6MM OFFSET (GREEN) Part Number 72201716. The product is an orthopedic device.

Lot NG808, Lot NG861, & Lot 1048031.

Orthopedic Devices

1

No

Nationwide Distribution -- CO, OH, PA, SD, TX & VA.

Mini Max Torque 2.6 mm diameter Drill Bit, Model #HCS-072-26 & 3.8 mm Countersink, Model # HCS-070-38. || Used to drill or cut bone prior to implantation of screws