Catalog ID 351.709S, Lot Numbers: 9913251; 9913252; 9913254; 9913256; 9913259; 9913260; 9950460; 9950461; 9950462; 9950463; 9950464; 9963747; 9963748; 9963749; 9963751; 9963752; 9963753; 9963755; 9963756; 9963757; 9985371; 9985372; 9985373; 9985374; H040508; H040509; H040510; H040511; H040512; H040517; H040518; H040519; H060103; H060104; H060105; H060106; H060107; H060108; H060114; H060115; H060116; H080034; H080035; H080036; H080037; H080038; H080039; H080040; H080041; H080081; H080082; H080083; H080084; H080085; H080086; H080087; H080088; H080089; H105527; H105528; H105529; H105530.

Orthopedic Devices

1

No

Distributed Nationwide

2.5 mm Reaming Rod W/Ball Tip 650 mm, Sterile

Catalog ID 355.041S, Lot Numbers: H085635; H087271; H094462; H111419; H136756

Orthopedic Devices

1

No

Distributed Nationwide

3.0 mm Guide Rod/950 mm with Smooth Tip, sterile

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.

Catalog number: 532.026 - All lots

Orthopedic Devices

1

No

Nationwide Distribution including the states of CO, LA, NY, and OK.

Synthes Oscillating Saw Attachment/Large w/Key for Small Battery Drive. || This surgical instrument motor and accessories are AC-powered, battery-powered or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver and saw blade.

part no. 396.396 (lot nos. T989765 and T989780), part no. 03.632.087 (lotT987270), part no. 03.812.005 (lot nos. T987734, T988931, and T987623), and part no. 03.820.129 (lot no. T988206).

Orthopedic Devices

1

No

Worldwided Distribution: USA (nationwide) including IL, MO, TX, WA and Internationally to Canada and Switzerland.

Synthes Material Mix (Adjustable Cervical Distractor-Right, Matrix Distractor Rack, T-PAL Spacer Remover, Implant Inserter) || Synthes Material Mix: Adjustable Cervical Distractor-Right is used to distract spine segment. Matrix Distractor Rack is used to distract the interbody disc space. T-PAL Spacer Remover is used to remove T-PAL spacer. Implant Inserter is used to insert the ProDisc implant.

all lots of part no. 03.802.039

Orthopedic Devices

1

No

Worldwide Distribution - USA (nationwide) and Internationally to Canada .

Synthes Implant Holder for Synfix (TM)-LR || the Synthes Implant Holder for Synfix (TM)-LR is a non-powered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery

Part Number 05.001.012, lot number AV18166

Orthopedic Devices

1

No

Worldwide Distribution - USA (nationwide) and Internationally to Mexico and Canada. .

Synthes Hand Switch - Electric Pen Drive, Part Number 05.001.012 || The Synthes Electric Pen Drive is indicated for screw insertion, pin and wire replacement, cutting of bone and metal, drilling, decorticating, shaping, and smoothing of bones and teeth in a wide variety of surgical procedures, including, but not limited to general orthopaedic trauma, foot, hand, maxillofacial, neurosurgical, oral, otolaryngolical, reconstructive, and spine surgery.

Part Number 352.040 - Lot # 9947895, L084498  Part Number 352.044 - Lot # 9916503 9916508,L000158,L000160,L000573,L000603,L000604,L000605,L000607,L000632 L082974

Orthopedic Devices

1

No

US Nationwide Distribution.

Synthes Flexible Shaft, Orthopedic manual surgical instrument || The Flexible shafts are intended for use as an optional reaming step in intramedullary nailing systems.

Part No. 352.085 with lot numbers 20141 through 24510, and 4399543 through 5870257

Orthopedic Devices

1

No

Worldwide Distribution: USA (Nationwide) and countries of: Canada and Mexico.

Synthes 8.5 MM Medullary Reamer || Product Usage: || An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, bmT, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.

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.

Catalog number 355.01. all lot numbers

Orthopedic Devices

1

No

The product was shipped to medical facilities nationwide.

Synthes Medullary Tubes

Model Catalog: 04.808.003 (Lot serial: ALL LOTS); Model Catalog: 04.808.004 (Lot serial: ALL LOTS); Model Catalog: 04.808.011 (Lot serial: ALL LOTS); Model Catalog: 04.808.006 (Lot serial: ALL LOTS); Model Catalog: 04.808.001 (Lot serial: ALL LOTS); Model Catalog: 04.808.002 (Lot serial: ALL LOTS); Model Catalog: 04.808.005 (Lot serial: ALL LOTS); Model Catalog: 04.808.010 (Lot serial: ALL LOTS); Model Catalog: 04.808.009 (Lot serial: ALL LOTS); Model Catalog: 04.808.008 (Lot serial: ALL LOTS); Model Catalog: 04.808.007 (Lot serial: ALL LOTS)

Orthopedic Devices

SYNEX II SYSTEM - CENTRAL BODY

See letter | All Lots

Orthopedic Devices

MD: Prosthesis, vertebral body

Part Number SD389.477, Lot Number 6913900

Orthopedic Devices

1

No

US distribution: PA only. .

Synthes Synapse SD Drill Guide, Part Number SD389.477, Lot Number 6913900 || Indicated for Hooks, Plate/Rods, Rods and Screws when intended to promote fusion of the cervical spine fusion of the cervical spine and occipitocervical junction (occiput-T3), the plate/rod, rod, hook and screw (3.2 mm cortex) components of the Synthes Cervifix; Axon and Synapse Systems are indicated for the following: -Degenerative Disk Disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies); -Spondylolisthesis; -Spinal Stenosis; -Fracture/dislocation; -Atlantoaxial fracture with instability; -Occipitocervical dislocation; -Revision of previous cervical spine surgery; and -Tumo

Ceterix catalog number CTX-001; Lot numbers: M150016 M150056 M150078 M150105 M150136 M150182 M150185 M150202 M150207 M150225 M150239.

Orthopedic Devices

1

No

Nationwide Distribution

NovoCut Suture Manager; Ceterix catalog number CTX-001. || General and Plastic Surgery: Intended for use in arthroscopic surgery.

Orthopedic Devices

Surgical equipment/ Anaesthesia

S8580 (8.0MM Drill Bit), lot numbers 322225 and 322226

Orthopedic Devices

1

No

Worldwide Distribution - USA including NJ, UT, GA, NY, PA, IL, LA, OH, CA, MS and Internationally to Canada, Japan, and Romania.

"***SENTINEL***Cannulated Drill Bit***S8580***8 X 229mm (9")***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***LOT***2012-03***". || This drill bit is an eccentric mono-fluted cutting edge for drilling bone tunnels in ACL and PCL reconstruction.

S8585 (8.5MM Drill Bit), lot number 322287

Orthopedic Devices

1

No

Worldwide Distribution - USA including NJ, UT, GA, NY, PA, IL, LA, OH, CA, MS and Internationally to Canada, Japan, and Romania.

"***SENTINEL***Cannulated Drill Bit***S8585***8.5 X 229mm (9")***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***LOT***2009-02***". || This drill bit is an eccentric mono-fluted cutting edge for drilling bone tunnels in ACL and PCL reconstruction.

Class I device, 510(K) exempt  Catalog Number: 48237028 Lot Number: 093653, 093654, 093655

Orthopedic Devices

1

No

Worldwide Distribution - USA (nationwide) and internationally to Australia, Canada, France, Germany, Netherlands, Japan, Spain, Denmark, Switzerland, and the United Kingdom.

Stryker XIA 3 TORQUE WRENCH || REF 48237028 || Manufactured by: || Stryker pine SAS || Z.I MARTICOT-33610-CESTAS-FRANCE || +33 (0)5.57.97.06.30 || http://www.stryker.com || Distributed in the USA by: || Stryker Spine, || 2 Pearl Ct. Allendale || NJ 07401-1677 USA || +1-201-780-8000 || The Xia 3/Mantis Redux/Specialty Audible Torque Wrenches are used to final tighten the blocker of the Xia 3/ Mantis Redux Polyaxial Screws, Hooks, Monoaxial Screws, Rod to Rod Connectors and Off-set connectors. The Torque Wrench is a t-handle deflection beam torque wrench with a 5 mm hex tip. The instrument allows the controlled application of 12 Nm torque via a visual indicator on the bell shaped cylinder just below the handle. The Specialty Audible Torque Wrench has an extra feature where it creates and audible "click" when the desired final tightening torque is reached.

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 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 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 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.