Home › Highridge Medical, LLC › Vital Spinal Fixation System
Vital Spinal Fixation System
Highridge Medical, LLC · Model 07.02114.011 · UDI-DI 03662663126229
HWX
Prescription
2
510(k) clearances
1,305
Adverse events
15
Recalls
298
Facilities
Description
Tap - Iliac
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-02-25 | Synthes (USA) Products LLC | A full lot swap between VOLT Locking Screw Tap 03.424.124 lot 68900P9 and Cortical Screw Tap 03.424.126 lot 68982P8, resulting in the bones taps having an incorrect thread. |
| 2026-02-25 | Synthes (USA) Products LLC | A full lot swap between VOLT Locking Screw Tap 03.424.124 lot 68900P9 and Cortical Screw Tap 03.424.126 lot 68982P8, resulting in the bones taps having an incorrect thread. |
| 2019-04-08 | Zimmer GmbH | An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. |
| 2013-05-03 | Surgical Instrument Service And Savings, Inc. | The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch. |
| 2012-04-13 | Smith & Nephew Inc | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. |
| 2010-10-15 | Orthohelix Surgical Designs Inc | The print for modified CSS depth gauges has inaccurate definition of the etched screw length. The error results in a length reading that is longer (5 mm in the case of the 7.0 and |
| 2010-10-15 | Orthohelix Surgical Designs Inc | The print for modified CSS depth gauges has inaccurate definition of the etched screw length. The error results in a length reading that is longer (5 mm in the case of the 7.0 and |
| 2010-10-15 | Orthohelix Surgical Designs Inc | The print for modified CSS depth gauges has inaccurate definition of the etched screw length. The error results in a length reading that is longer (5 mm in the case of the 7.0 and |
| 2010-04-21 | Blackstone Medical, Inc. | Certain lots of the non-cannulated Modular Bone Taps used with the Firebird Spinal Fixation Systems may contain a manufacturing non conformance resulting in the taps creating a si |
| 2010-04-21 | Blackstone Medical, Inc. | Certain lots of the non-cannulated Modular Bone Taps used with the Firebird Spinal Fixation Systems may contain a manufacturing non conformance resulting in the taps creating a si |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.