BEUDAMED
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    Songer Spinal Cable System, Single Cable, Crimp, Bar, Stainless Steel, Sterile. The DePuy Spine Cable System can be utilized anywhere monofilament wire has been previously found to be indicated.

    FDA Enforcement
    Class II ·Terminated·RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)·July 15, 2015

    Songer Spinal Cable System, Single Cable, Crimp, Bar, Stainless Steel, Sterile. The DePuy Spine Cable System can be utilized anywhere monofilament wire has been previously found to be indicated.

    FDA Recall
    Terminated ·RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)·Product code JDQ·May 29, 2015

    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.

    FDA Recall
    Terminated ·DePuy Spine, Inc.·Product code OCJ·March 22, 2011

    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.

    FDA Recall
    Terminated ·DePuy Spine, Inc.·Product code OCJ·March 22, 2011

    PIPELINE LS ACCESS SYSTEM, Holding Clip The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor.

    FDA Recall
    Terminated ·DePuy Spine, Inc.·Product code GCC·July 31, 2013

    PIPELINE LS ACCESS SYSTEM, 2nd Dilator, 10 mm, Insulated The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor.

    FDA Recall
    Terminated ·DePuy Spine, Inc.·Product code GCC·July 31, 2013

    PIPELINE LS ACCESS SYSTEM, 15 Dilator, 5 mm, Insulated The PIPLINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor.

    FDA Recall
    Terminated ·DePuy Spine, Inc.·Product code GCC·July 31, 2013

    PIPELINE LS ACCESS SYSTEM, 3rd Dilator, 14 mm Insulated The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor.

    FDA Recall
    Terminated ·DePuy Spine, Inc.·Product code GCC·July 31, 2013

    PIPELINE LS ACCESS SYSTEM, 4th Dilator, 18 mm, Insulated The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor.

    FDA Recall
    Terminated ·DePuy Spine, Inc.·Product code GCC·July 31, 2013

    DePuy Spine Bremer 3-D Halo Crown System Product Code: 2923-01-100

    FDA Recall
    Terminated ·DePuy Spine, Inc.·Product code HWC·October 10, 2006

    Extra Long Skull Pins, DePuy Spine Bremer Halo System Product Number: AC018

    FDA Recall
    Terminated ·DePuy Spine, Inc.·Product code HWC·October 10, 2006

    Large Halo Crown w/HI Skull pins, DePuy Spine Bremer Halo System Product Number: HT026HI

    FDA Recall
    Terminated ·DePuy Spine, Inc.·Product code HWC·October 10, 2006

    DePuy Spine VIPER POLY SCREW 5.5 8 X100MM Tl Product Code: 1867-15-899 Spinal Implant Component.

    FDA Recall
    Terminated ·DePuy Spine, Inc.·Product code NKB·November 7, 2012

    DePuy Spine VIPER POLY SCREW 5.5 8 X80MM Tl Product Code: 1867-15-880 Spinal Implant Component.

    FDA Recall
    Terminated ·DePuy Spine, Inc.·Product code NKB·November 7, 2012

    CONFIDENCE SPINAL CEMENT SYSTEM KIT, Product Code: 2839-13-000 The CONFIDENCE Spinal Cement System is intended for percutaneous delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures of the vertebral body during vertebroplasty or kyphoplasty procedures.

    FDA Recall
    Terminated ·DePuy Spine, Inc.·Product code NDN·April 17, 2013

    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.

    FDA Recall
    Terminated ·DePuy Spine, Inc.·Product code KWP·February 11, 2009

    DePuy Spine VIPER POLY SCREW 5.5 8 X70MM Tl Product Code: 1867-15-870 Spinal Implant Component.

    FDA Recall
    Terminated ·DePuy Spine, Inc.·Product code NKB·November 7, 2012

    Aegis Torque Handle CATALOG NO. : 2871-10-800. A spinal surgical instrument used on the AEGIS Anterior Lumbar Plate System.

    FDA Recall
    Terminated ·DePuy Spine, Inc.·Product code KWQ·November 20, 2015

    DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SCREW 4.0 x 18mm Item Code: 186850018 The SKYLINE Anterior Cervical Plate System is indicated for stabilization from C2 to C7 for degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), pseudoarthosis , trauma (i.e., fracture or dislocation), deformities (i.e. cervical kyphosis, and/or lordosis), tumor, spinal canal stenosis, and cervical myelopathy.

    FDA Recall
    Terminated ·DePuy Spine, Inc.·Product code KWQ·October 12, 2016

    Concorde Lift, Lordotic Expandable Interbody Device, spinal fusion implant 9x23 (197809023L), 9x27 (197809027L), 11 x 23 (197811023L), 11x27 (197811027L), 9x23 (US197809023L), 9x27 (US197809027L)

    FDA Recall
    Terminated ·DePuy Spine, Inc.·Product code MAX·April 8, 2019