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Mergence-A Preparation Instrumentation
Highridge Medical, LLC · Model 07.01225.001 · UDI-DI 03662663109673
10
510(k) clearances
602
Adverse events
3
Recalls
371
Facilities
Description
Nerve Probe, Right Angle
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-12-03 | Sklar Instruments | Reports of various packaging issues that may result in a breach of the sterile barrier. |
| 2014-12-02 | Zimmer Trabecular Metal Technology, Inc. | During cleaning, two separate units of the NexGen Tibial Base plates did not fit with the Tibial Base Plate handle. |
| 2013-09-11 | SpineFrontier, Inc. | Bone Probes used to create a pathway in pedicle bone were manufactured and marked to incorrect specifications. |
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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.