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neuromate tool guide
RENISHAW MAYFIELD · Model Tool guide OD15 - Standard guide (XX = internal diameter) · UDI-DI 03662724000055
1
510(k) clearances
42,840
Adverse events (104 deaths)
197
Recalls
248
Facilities
Description
Tool adaptor or guide bushing to accommodate various diameters of instruments. Only the diameter of the central hole is adapted.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-03-19 | Elekta, Inc. | Locking mechanisms may not properly secure to the Arc system, resulting in shifting of coordinates during procedures. |
| 2025-11-12 | Howmedica Osteonics Corp. | When the device is activated during surgery, the device software issues an error message "Instrument Face Mask (6001385000000) is not valid for this application" resulting in an in |
| 2025-09-30 | Elekta, Inc. | Due to increased risk that paint flakes from the engravings may separate from the device and there is the possibility that the flake may inadvertently enter the wound |
| 2024-10-04 | FHC, Inc. | A complaint was received (MDR 3002250546-2024-00003) prompting an investigation. The investigation revealed a schematic for a spacer tube which is too long relative to the size of |
| 2024-09-25 | Elekta Instrument AB | Elekta has become aware that Disposable Biopsy Needles can contain some microscopic debris on the inside of the biopsy needle. The material in the debris is stainless steel, same m |
| 2024-03-26 | Medtronic Navigation, Inc. | Due to a software issue, there is the potential for a missing digit, letter, or decimal in either the "distance to target" or "tip stop point" display during navigation. |
| 2024-03-15 | Elekta Instrument AB | Elekta has become aware that Disposable Biopsy Needles (911933) from one batch (837838839) can contain some microscopic debris on the inside of the biopsy needle. The material in t |
| 2024-02-26 | Navinetics Inc | Defective Skull Anchor Key. After attachment of the single use Skull Anchor Key to the patient, the user was unable to attach the CT Localizer to perform stereotactic Imaging. Atta |
| 2023-12-11 | Globus Medical, Inc. | Sterile-packed Cranial Drills may not be sterile due to a breach in the packaging and/or may have discoloration near the drill tip. |
| 2023-12-11 | Globus Medical, Inc. | Sterile-packed Cranial Drills may not be sterile due to a breach in the packaging and/or may have discoloration near the drill tip. |
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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.