Synthes Spine

Lot numbers TM00119 exp 6/30/05, TM00122 exp 7/31/04, TM00124 exp 7/31/04, TM00128 exp 9/30/05, TM00150 exp 10/31/06, TM00155 exp 3/9/07, TM00160 exp 12/29/08, TM00172 exp 3/30/09, TM00197 exp 7/31/09, TM00220 exp 9/7/09, TM00221 exp 9/7/09, TM00260 exp 3/10/10, TM00271 exp 4/28/10, TM00295 exp 10/10/10, TM00315 exp 2/28/11, TM00322 exp 4/13/11, 4859489 exp 7/30/05, 4859490 exp 6/30/05, 4859492 exp 7/31/05, and TM00341 exp 3/12/12.

Orthopedic Devices

2

Yes

Worldwide Distribution -- USA including states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV and the country of Canada.

In Situ Bender Cutter Kit Wide Sterile, Catalog number 530.521S || Used with Synthes' Rapid Resorbable Fixation System which is intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton in adults and children.

Lot numbers: TM00051 exp 9/24/02, TM00072 exp 03, TM00098 exp 1/31/05, TM00151 exp 10/31/05, TM00156 exp 3/9/07, TM00161 exp 12/29/07, TM00173 exp 3/30/08, TM00192 exp 5/30/08, TM00340 exp 1/3/11, TM00261 exp 3/10/09, TM00280 exp 7/31/09, TM00300 exp 10/10/09, TM00316 exp 2/27/10, TM00324 exp 4/8/10, and 4691525 exp 1/31/05.

Orthopedic Devices

2

Yes

Worldwide Distribution -- USA including states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV and the country of Canada.

In Situ Bender Cutter Kit Narrow Sterile, Catalog number 530.522S. || Used with Synthes' Rapid Resorbable Fixation System which is intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton in adults and children.

Lot numbers: 2317363, 2331806, 2331810, 2387975, 2387976, 2401982, 5637286, 5644605, 5660377, 5664629, 5826243, and 5826244.

Orthopedic Devices

2

Yes

Class II Recall - Worldwide Distribution --- USA including states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, PA ,SC, TN, TX, UT, VA, WA, and WI, and countries of Canada and Switzerland.

Low Profile U-Joint Driver for the SynFix Mini-Open System, Catalog number 03.802.231. || The Synthes SynFix LR is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The interior of the spacer component of the SynFix LR can be packed with autograft.

Lot numbers: P06J01 exp 9/30/07; P06J02 exp 9/30/07; P06M01 exp 12/31/07; P06M02 exp 12/31/07; P07D02 exp 4/30/08; P07H01 exp 8/31/08; and P07J01 exp 9/30/08.

Orthopedic Devices

2

Yes

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.

NFix II System 150 mm, Catalog number NX60150-1 || spinal fusion surgery

Lot number P07G01 exp 7/31/08

Orthopedic Devices

2

Yes

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.

NFix II System 200 mm, Catalog number NX60200-1. || spinal fusion surgery