Synthes Spine

Catalog # 03.617.902 - All lots

Orthopedic Devices

2

Yes

Distributed Nationwide and Canada.

Synthes Zero-P StarDrive Screwdriver Shaft, T8, self-retaining, quick coupling, for use in spinal fusion surgery. Catalog # 03.617.902 Technique Guide.

Lot Numbers: UR76230, US89403, US94671, US97826, 5674035, US90907, US94396 AND US97022.

Orthopedic Devices

2

Yes

Worldwide Distribution -- US (states of AR, CA, CO, CT, FL, IA, IL, LA, MD, ME, MI, MN, MS, NJ, NY, OK, PA, SC, TX, and UT) and country of Switzerland.

Square Nut MR Safe, Catalog Number 03.311.060. || The Square Nut MR Safe is used in conjunction with Synthes Distraction Osteogenesis Ring Systems. It can be used to secure components together or as a means of bone distraction/compression. Each side of the Square Nut is etched with a number, 1-2-3-4, which can be referenced during distraction/compression. Distraction of bone typically occurs a a rate of 1mm/day. The patient may be instructed to turn the nuts 1/4 turn four times per day, accomplishing 0.25mm per 1/4 turn. The etched numbers offer reference points to the surgeon who instructs the patient on distraction technique.

Catalog number 530.522S - Lot number TM00324 exp 4/8/10

Orthopedic Devices

2

Yes

Nationwide distribution: AL, CA, KS, LA, MD, NJ, NV, NY, OR, PA, TX, and UT

Synthes InSitu Bender Cutter Kit Narrow Sterile Catalog number 530.522S, used with Synthes Rapid Resorbable Fixation System for craniofacial skeleton fracture repair and reconstructive procedures.

Catalog number 530.521S - Lot number TM00322 exp 4/13/11

Orthopedic Devices

2

Yes

Nationwide distribution: AL, CA, KS, LA, MD, NJ, NV, NY, OR, PA, TX, and UT

Synthes InSitu Bender Cutter Kit Wide Sterile Catalog number 530.521S, used with Synthes Rapid Resorbable Fixation System for craniofacial skeleton fracture repair and reconstructive procedures.

lot numbers P07M01 exp 12/31/08; P07M03 exp 12/31/08; P06H01 exp 8/31/07; P06M01 exp 12/31/07; and P06J01 exp 9/30/07

Hematology and Pathology Devices

2

No

Worldwide: AK, AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NH, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV. OUS: Germany, Denmark, Switzerland, and Korea.

NFlex Stabilization System 150 mm, Catalog number NF60150-1. || spinal fusion surgery