Device Recall DePuy Spine

All lots

Orthopedic Devices

1

No

Worldwide Distribution-USA (nationwide) and the countries of Canada, Austria, China, Croatia, Czech Republic, France, Germany, Greece, Hungary, Italy, Lebanon, Netherlands, New Zealand, Poland, Russian Federation, Singapore, South Africa, Spain, Switzerland, Turkey, UAE, and UK.

Depuy Spine Side Fire Needles 13G X 4IN Side-Fire Needle, part of the Confidence Spinal Cement System || Product Code 283904413. || The Confidence Side Fire Needle is used to place bone cement in an intra-vertebral fashion at a desired location. the cement extrudes fro the needle through a port on the side of the needle.

All lots

Orthopedic Devices

1

No

Worldwide Distribution - USA (nationwide) and internationally to Belgium, Egypt, Ireland, Italy, Portugal, and the UK.

DePuy Spine EXPEDIUM Offset Torque Wrench || Product Code 2797-29-510 || The device is intended for use during the final tightening of an Expedium Offset Spinal Construct.

Product Code: 2894-10-300; Lot Number: 1208NT.

Orthopedic Devices

2

Yes

Nationwide Distribution -- Including states of MD, PA, NC, MO, NV, AZ, WI and CT.

DePuy Spine Expedium SFX Cross Connector System Torque Driver Shaft, Non-Sterile, REF: 2894-10-300. || Intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the spine.

Lot Code: HLPB4G

Orthopedic Devices

1

No

Worldwide distribution: USA including states of: AZ, IA, LA, TX, NE, NJ ,NY, PA, VA, and WA; and countries of: Canada, Australia, Belgium, France,Hungary, Italy, Malaysia, Solvenia, UK, South Africa, Switzerland, and UAE.

Confidence¿ Diamond Tip Introducer Needle 11G x 6-Inch || Product Code: 2839-03-611 || The Confidence Needles are supplied sterile. They are used to place bone cement percutaneously at a desired location. They come in a variety of sizes (length and diameter) and configurations (Bevel tip, Diamond tip). The cement extrudes from the end of the cannulated needle with the exception of the side hole needle which extrudes cement from a portal on the side of the tube near the distal end. The needle is placed under fluoroscopy prior to cement delivery. The needle is also sometimes used in MIS cases to place the guide wire that is used to assist in the placement of the pedicle screw.

Lot Code: HLPB4F

Orthopedic Devices

1

No

Worldwide distribution: USA including states of: AZ, IA, LA, TX, NE, NJ ,NY, PA, VA, and WA; and countries of: Canada, Australia, Belgium, France,Hungary, Italy, Malaysia, Solvenia, UK, South Africa, Switzerland, and UAE.

Confidence¿ Introducer Needle Side Hole 13G x 4-Inch || Product Code: 2839-04-413 || The Confidence Needles are supplied sterile. They are used to place bone cement percutaneously at a desired location. They come in a variety of sizes (length and diameter) and configurations (Bevel tip, Diamond tip). The cement extrudes from the end of the cannulated needle with the exception of the side hole needle which extrudes cement from a portal on the side of the tube near the distal end. The needle is placed under fluoroscopy prior to cement delivery. The needle is also sometimes used in MIS cases to place the guide wire that is used to assist in the placement of the pedicle screw.