Home › Highridge Medical, LLC › PathFinder NXT Minimally Invasive Pedicle Screw System
PathFinder NXT Minimally Invasive Pedicle Screw System
Highridge Medical, LLC · Model 1913-020 · UDI-DI 03662663161237
GDF
Prescription
10
510(k) clearances
227
Adverse events
20
Recalls
236
Facilities
Description
Bevel Tip Targeting Needle with Luer Lock
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-07-07 | Advance Medical Designs, Inc. | Ultrasound gel mislabeled with inappropriate use. |
| 2023-07-07 | Advance Medical Designs, Inc. | Ultrasound gel mislabeled with inappropriate use. |
| 2021-08-05 | M.D.L. S.r.l. | Sterility assurance may be compromised. |
| 2017-03-28 | Bard Peripheral Vascular Inc | It may be at risk of containing a non-MR compatible GHIATAS Beaded Breast Localization Wire instead of a MR compatible GHIATAS Beaded Breast Localization Wire. |
| 2016-08-02 | Hologic, Inc | Tip Breakage at the glue joint between the obturator body and tip |
| 2016-08-02 | Hologic, Inc | Tip Breakage at the glue joint between the obturator body and tip |
| 2016-02-04 | Stryker Instruments Div. of Stryker Corporation | During an evaluation of the product packaging, it was determined that there is a potential for the product to cause damage to the packaging, creating a possible breach in sterility |
| 2016-02-04 | Stryker Instruments Div. of Stryker Corporation | During an evaluation of the product packaging, it was determined that there is a potential for the product to cause damage to the packaging, creating a possible breach in sterility |
| 2016-02-04 | Stryker Instruments Div. of Stryker Corporation | During an evaluation of the product packaging, it was determined that there is a potential for the product to cause damage to the packaging, creating a possible breach in sterility |
| 2016-02-04 | Stryker Instruments Div. of Stryker Corporation | During an evaluation of the product packaging, it was determined that there is a potential for the product to cause damage to the packaging, creating a possible breach in sterility |
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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.