Spinal Concepts, Inc

All lots in the market.

Orthopedic Devices

2

Yes

Nationwide

One-level Ant-Cer Plates (Assembly Level). 1706-1024, 1706-1026, 1706-1028, 1706-1030, 1706-1032, and product literature. Devices are manufactured by Spinal Concepts, Inc., An Abbott Laboratories Company

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

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 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