Spinal Vertebral Body Replacement Device

X-CORE 2 Ti Core, Static. Part of the NuVasive X-Core Expandable VBR System used with spinal fixation.

Potential that insert will be unable to disengage from the vertebral body replacement device/implant

Synthes XRL Medium Trial - Central Body, an instrument used as part of the Synthes XRL System, a vertebral body replacement device. For spinal surgery. The Sy

Two lots of the Synthes XRL Medium Trial-Central Body device were incorrectly etched with the incorrect dimensions for height.

Titan Spine Endoskeleton TA Implant products.

Titan Spine LLC, is conducting a recall on the Endoskeleton TA VBR products. The labeling accompanying this device contains incorrect indications for use.

Enduramesh Corpectomy Spacer System

The firm voluntarily recalled the device after they discovered that the sterilization recommendations on the product insert did not pass sterilization validation.

ENDURAMESH CORPECTOMY SPACER SYSTEM 013MM, 017MM, 023MM by varying heights. Dist. By: Lucero Medical, PO Box 67, Richfield, Ohio 44826

During an FDA inspection the firm was informed that the device marketed is not the device cleared for the 510K associated with the device. The product is sold unlabeled.

Theken L"POD" Titanium Vertebral Body Replacement System, Vu c"POD" PEEK-Optima Vertebral Body Replacement System, c"POD" Titanium Vertebral Body Replacement Sy

Certain Theken Spine Vertebral Body Replacement Systems were distributed (i) without certain components (spacers and set screws) that are necessary for their use as vertebral body replacements, and (ii) with a component (insertion tool) that is not relevant to the devices' intended use.

Vu a-POD Intervertebral Body Fusion Device. Packaged as surgical kits containing all implants and instruments required for a procedure. Also packaged as indiv

The IFU provided with the device contains incorrect information in the Indications for Use Section, stating the following: The Theken Spine Vu a"POD Intervertebral Body Fusion Device is intended for use as a stand alone implant when used with the SpinPlate provided in the set.

Orthofix Spinal Implants; Pillar SA PEEK Spacer System Instrument Case.

The Pillar SA Implant Insertion Instrument 49-1100 may experience resistance in turning the activation knob while releasing an implant after intra-operative positioning.

Synthes USA, TI Synex (TM) II Central Body 14mm - 19mm, Catalog number 04.808.001.

loss of device height

Synthes USA, TI Synex (TM) II Central Body 17mm - 25mm, Catalog number 04.808.002.

loss of device height