261 results
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10ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Multi Vector Distractor Pin Holding Clamp, limited bone stock The holding clamp is part of the Multi Vector Distractor which cis used for mandibular bone lengthening, including conditions such as congenital mandibular deficiencies or post-traumatic defects. The Multi Vector Distractor can be utilized to perform bone transport procedures as an alternative to bone grafts and free flaps.
FDA Enforcement
Class II
·Terminated·Synthes USA HQ, Inc.·July 24, 2013
Synthes Titanium Midface Distractor, MR Conditional, Part number 487.982. For temporary stabilization and gradual lengthening of the cranial or midfacial bones.
FDA Enforcement
Class II
·Terminated·Synthes USA HQ, Inc.·March 20, 2013
Large Combination Clamp/Large External Fixation System, Part Number 390.005 Product Usage: Synthes Large External Fixation is intended for use to provide treatment for long bone and pelvic fractures that require external fixation.
FDA Enforcement
Class II
·Terminated·Synthes USA HQ, Inc.·March 20, 2013
Synthes Soft Tissue Retractor Small Extendible. Offset blade facilitates easy preparation of the epipereosteal cavity for percutaneous plate insertion.
FDA Enforcement
Class II
·Terminated·Synthes USA HQ, Inc.·December 11, 2013
Large Buttress Compression Nut For Blade Guide Sleeve TFN The Synthes Large Buttress Compression Nut For Blade Guide Sleeve TFN is intended to treat stable and unstable pertrochanteric fractures, intertrochanteric fractures, basal neck fractures, and combinations there of.
FDA Enforcement
Class II
·Terminated·Synthes USA HQ, Inc.·December 4, 2013
3.7mm and 5.0mm Dynamic Locking Screw (DLS) Product Usage: 3.7mm and 5.0mm Dynamic Locking Screw (DLS) in combination with Synthes Locking Compression Plates (LCP) are intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.
FDA Enforcement
Class II
·Terminated·Synthes USA HQ, Inc.·December 4, 2013
Titanium Trochanteric Fixation Nail (TFN)System Intended to treat stable and unstable fractures of the proximal femur.
FDA Enforcement
Class II
·Terminated·Synthes USA HQ, Inc.·December 11, 2013
Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
FDA Enforcement
Class II
·Terminated·Synthes USA HQ, Inc.·October 23, 2013
Synthes Oracle Spacer System Slap Hammer, Part Number 03.809.690, Lot Number 3723847 The Oracle Spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The Oracle Spacer is indicated as a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a diseased vertebral body resected or excised during partial and total vertebrectomy procedures or the treatment of tumor or trauma (i.e., fracture), to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of the collapsed vertebral body. The Slap Hammer, 03.809.690, is a dual sided device with two separate attachment options. The Slap Hammer allows a user (surgeon) to remove a previously placed trial implants.
FDA Enforcement
Class II
·Terminated·Synthes USA HQ, Inc.·October 2, 2013
Norian CRS Rotary Mixer Cement 10cc sterile
FDA Recall
Terminated
·Synthes USA (HQ), Inc.·Product code GXP·September 14, 2009
Synthes T1 Matrix Locking Cap of the Synthes Matrix System, Part Number 04.632.000. Intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation.
FDA Recall
Terminated
·Synthes USA (HQ), Inc.·Product code NKB·March 11, 2011
02.122.590S, 90mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults.
FDA Recall
Terminated
·Synthes USA (HQ), Inc.·Product code KTW·October 27, 2010
02.122.620, 120mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults.
FDA Recall
Terminated
·Synthes USA (HQ), Inc.·Product code KTW·October 27, 2010
02.122.565, 65mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults.
FDA Recall
Terminated
·Synthes USA (HQ), Inc.·Product code KTW·October 27, 2010
02.122.561S, 60mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults.
FDA Recall
Terminated
·Synthes USA (HQ), Inc.·Product code KTW·October 27, 2010
02.122.595S, 95mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults.
FDA Recall
Terminated
·Synthes USA (HQ), Inc.·Product code KTW·October 27, 2010
02.122.591S, 90mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults.
FDA Recall
Terminated
·Synthes USA (HQ), Inc.·Product code KTW·October 27, 2010
02.122.621S, 120mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults.
FDA Recall
Terminated
·Synthes USA (HQ), Inc.·Product code KTW·October 27, 2010
02.122.600S, 100mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults.
FDA Recall
Terminated
·Synthes USA (HQ), Inc.·Product code KTW·October 27, 2010
SYNTHES TI MATRIXMANDIBLE SAGITTAL SPLIT PL 1.5MM THK/4H/42MM, Catalog # SD448.004. Synthes Titanium Matrix Mandible Sagittal Plates and Instruments are intended for general use in orthognathic surgery.
FDA Recall
Terminated
·Synthes USA (HQ), Inc.·Product code JEY·September 3, 2009