10,000 results
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63ms
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Sources: EU EUDAMED, US FDA
Set Screw 5.5 mm Rod - Model #7703-1600. Product Usage: The titanium alloy set screw is used to seat a 5.5 mm titanium alloy, commercially pure titanium or cobalt chrome rod into a pedicle screw tulip in order to create a spinal fixation construct. The Set Screw is provided to the user non-sterile and is used across three Biomet Spine product lines; Silverton Spinal Fixation System (Silverton), Silverton-D Spinal Fixation System (Silverton-D) and Telluride Minimally Invasive Spinal Fixation System (Telluride). The primary packaging for the Set Screws is an aluminum sterilization case that holds both implants and instruments used collectively as part of a system. Additionally, Set Screws can be packaged in a heat sealed polypropylene bag for single device distribution.
FDA Recall
Terminated
·Biomet Spine, LLC·Product code NKB·November 30, 2012
Set Screw 5.5 mm Rod - Model #7703-1600. Product Usage: The titanium alloy set screw is used to seat a 5.5 mm titanium alloy, commercially pure titanium or cobalt chrome rod into a pedicle screw tulip in order to create a spinal fixation construct. The Set Screw is provided to the user non-sterile and is used across three Biomet Spine product lines; Silverton Spinal Fixation System (Silverton), Silverton-D Spinal Fixation System (Silverton-D) and Telluride Minimally Invasive Spinal Fixation System (Telluride). The primary packaging for the Set Screws is an aluminum sterilization case that holds both implants and instruments used collectively as part of a system. Additionally, Set Screws can be packaged in a heat sealed polypropylene bag for single device distribution.
FDA Enforcement
Class II
·Terminated·Biomet Spine, LLC·March 4, 2015
LANX, REF, PCR8XXX-XXX, LOT, RXONLY. Packaged within aluminum sterilization case. Product Usage: The Durango implant is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2S1.
FDA Enforcement
Class II
·Terminated·Biomet Spine LLC.·November 26, 2014
LANX, REF, PCR8XXX-XXX, LOT, RXONLY. Packaged within aluminum sterilization case. Product Usage: The Durango implant is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2S1.
FDA Recall
Terminated
·Biomet Spine LLC.·Product code MAX·March 9, 2011
Timberline Cranial Caudal and Posterior Blades, 40 - 180mm Model # 8734-2XXX, 8734-5XXX is a reusable device provided within an aluminum sterilization tray along with other instruments for use in a Timberline procedure Timberline Anchored Lateral Retractable Drills are used with the Timberline Lateral System to establish access into the vertebrae for the screws utilized to anchor the plate to the vertebrae.
FDA Enforcement
Class II
·Terminated·Biomet Spine, LLC·February 18, 2015
Lineum® OCT
FDA UDI
BIOMET SPINE LLC·00880304986299·
Timberline® Lateral Interbody Fusion System
FDA UDI
BIOMET SPINE LLC·03662663056465·
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FDA UDI
BIOMET SPINE LLC·00888480170488·
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FDA UDI
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FDA UDI
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FDA UDI
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FDA UDI
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FDA UDI
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FDA UDI
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FDA UDI
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FDA UDI
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Timberline® MPF Lateral Interbody Modular Plate Fixation System
FDA UDI
BIOMET SPINE LLC·00887868197628·
Timberline® MPF Lateral Interbody Modular Plate Fixation System
FDA UDI
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POLARIS 6.35 TI SPINAL SYSTEM
FDA UDI
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FDA UDI
BIOMET SPINE LLC·00888480542568·