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Pro-Link Stand-Alone Cervical Spacer System
Life Spine, Inc. · Model 2015-0005 · UDI-DI 00190837060497
OVE
Prescription
1
510(k) clearances
2,375
Adverse events
12
Recalls
234
Facilities
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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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.