Devices

Device Recall Endoskeleton Locking Bone Screw Assembly

Model / Serial
Lot numbers: V03, V05, V06
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Distributed in the states of CA, TX, OK, MA, NY, IN, OR, and GA.
Product Description
Titan Spine Endoskeleton Locking Bone Screw Assembly, which is part of the Endoskeleton TCS Interbody Fusion Device, spinal implant. Part Numbers / Product Description: 5302-3514 / 03.5 x 14mm Locking Screws; || 5302-3516 / 03.5 x 16mm Locking Screws; || 502-3518 / 03.5 x 18mm Locking Screws; || 5302-3814 / 03.8 x 14mm Locking Screws; || 5302-3816 / 03.8 x 16 mm Locking Screws; || 5302-3818 / 03.8 x 18mm Locking Screws.
Manufacturer
TITAN SPINE, LLC
1 Event
- Recall of Device Recall Endoskeleton Locking Bone Screw Assembly

Manufacturer

TITAN SPINE, LLC

Manufacturer Address
TITAN SPINE, LLC, 6140 W Executive Dr, Suite A, Mequon WI 53092-4499
Manufacturer Parent Company (2017)
Titan Spine LLC
Source
USFDA

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