GluOn-IF Stand-alone ACIF Cage System
GS Medical Co., Ltd. · Model 6081-0017 · UDI-DI 08809885711368
Description
The CYGNUS-C Standalone ACIF System cages are designed for restoring the height of the intervertebral space after resection of the disc while also providing biomechanical stability with the addition on an integrated plate. This integrated plate allows for the user to bypass using an additional plate as seen with traditional ACIF spacers. The CYGNUS-C Standalone ACIF System devices consist of implants available in various heights and lordotic configurations with an open architecture to accept packing of bone graft material. The Subject device also contains supplementary fixation screw. The intervertebral body fusion devices are made of hydroxyapatite polyether-ether-ketone (HA PEEK OPTIMA LT1) body with a titanium alloy (Ti-6Al-4V) plate and X-ray (radioopaque) markers made of tantalum. The supplementary screws are made up of titanium alloy (Ti-6Al-4V).
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-08-23 | Stryker Spine | Labeling Correction: Instructions For Use (IFU)-Updated electronic Rev 5, specific language for indications for use for the United States and Canada was inadvertently removed. |
| 2021-09-08 | K2M, Inc | Units may arrive with missing pins and/or in a state in disassembly. Pins dislodging from the instrument during a procedure may enter the surgical cavity, requiring intraoperative |
| 2021-09-02 | Medtronic Sofamor Danek USA Inc | Engraving on implants may not match what is listed on the pouch labels. |
| 2019-06-13 | SpineFrontier, Inc. | There is a potential for the driver to bind up when attempting to advance the intervertebral body fixation screw. |
| 2019-01-30 | U&I CORP. | The vertical dimensions of screw-hole position in some standalone cages might be out of range in engineering drawings. A possibility exists of screw pullout, lossening, instability |
| 2017-07-07 | Amendia, Inc | Incorrect direct marking and color identification for the affected lot of Ceres Self-Drilling Variable Screws. Although the laser mark and color identify the screws as 12 mm in len |
| 2016-11-22 | Amendia, Inc | Absent tantalum market pin. |
| 2015-09-28 | Exactech, Inc. | Incorrect external and internal packaging labels. Exactech has identified nineteen (19) Acapella One Interbody Fusion Device Lordotic (05-090-01-1610) were packaged as Acapella One |
| 2015-07-20 | TITAN SPINE, LLC | Titan Spine is recalling specific Endoskeleton TCS Integrated Locking Bone Screw Assembly due to the locking bone screw collars not 'locking'. |
| 2015-02-20 | TITAN SPINE, LLC | The TCS Straight Hexlobular #6 Drivers (5210-1004) tip sheared off during use in procedures that involved patients with dense bones. As a result of this malfunction, Titan Spine, |
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