Spinal Concepts, Inc

2851-1-01 lot number 18YH, 2851-1-30 lot number 18YJ, 2851-2-01 lot number 18YK, 2851-2-30 lot number 18YL, 2851-3-01 lot number 18YM, 2851-3-30 lot number 18YP, 2851-4-01, lot number 18YQ, 2851-4-30 lot number 18YR, 2851-4-31 lot number 18YS, 2851-5-01 lot number 18YT, 2851-5-30 lot number 18YW, 2852-2 lot number 18YT, 2852-4 lot number 18YT, 2854-1 lot number 18YX, 2857-1 lot number 18YZ, 2857-2 lot number 18ZA, 2862-1 lot number 18YY, 2858-1 lot number 18ZB, 2859-1 lot number 18ZC, and 2861-5 lot number 18ZD

Orthopedic Devices

2

Yes

Product was distributed domestically in the following states: TN, MI, KY, CA, CO, OH, KS, WA, TX, NY, AZ, PA, MA, UT, MO, IN, NV, OR, SD, IL, NJ, WI, OK, FL, GA, VA, NC, MD

Harmony MIS Life Instruments, Lumbar Spacer Systems manufactured by Spinal Concepts, Austin, Texas. Part numbers 2851-1-01, 2851-1-30, 2851-2-01, 2851-2-30, 2851-3-01, 2851-3-30, 2851-4-01, 2851-4-30, 2851-4-31, 2851-5-01, 2851-5-30, 2852-2, 2852-4, 2854-1, 2857-1, 2857-2, 2862-1, 2858-1, 2859-1, and 2861-5

All Codes

Orthopedic Devices

2

Yes

Product was distributed to consignees in KY, CA, CO, OH, IN, WA, KS, TX, NY, AZ, NJ, MI, PA, OK, MA, UT, MO, PA, OR, SD, MN, IL, WI, FL, NC, AL, MD, VA, NM, LA. Product was also distributed to the following foreign countries: Germany, Japan, and Italy

955-4 BacFix Coldwelder II with angled tip, manufactured by Spinal Concepts, Austin, Texas

All codes

Orthopedic Devices

2

Yes

Product was distributed to consignees in KY, CA, CO, OH, IN, WA, KS, TX, NY, AZ, NJ, MI, PA, OK, MA, UT, MO, PA, OR, SD, MN, IL, WI, FL, NC, AL, MD, VA, NM, LA. Product was also distributed to the following foreign countries: Germany, Japan, and Italy

955-5 BackFix Coldwelder II with straight tip manufactured by Spinal Concepts, Austin, Texas

All devices lot number 10RY and earlier of the following part numbers were removed from the market in 2002: 407-1020; 407-1022; 407-1024; 407-1026; 407-1028; 407-1030; 407-1032; 407-1034; 407-2236; 407-2238; 407-2240; 407-2242; 407-2244; 407-2246; 407-2248; 407-2250; 407-2252; 407-2254

Orthopedic Devices

2

Yes

Systems were distributed to hospitals in CA, IL, IN, NC, MS, PA, NY and VA

SC-AcuFix Thinline Low-Profile Anterior Cervical Plate System manufactured by Spinal Concepts, Inc., An Abbott Laboratories Company, Austin, Texas

All lots

Orthopedic Devices

2

Yes

Nationwide

1757-1: Compressor/Distractor Instrument (aka Plate Distractor Forceps), and product literature. Devices are manufactured by Spinal Concepts, Inc., An Abbott Laboratories Company