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NDI Passive Spheres

Northern Digital Inc · Model 8801002 · UDI-DI 00805832020048

HAW Prescription

510(k) clearances

42,840

Adverse events (104 deaths)

197

Recalls

248

Facilities

Description

Disposable Reflective Spheres attached to reference frames and surgical instruments for use during surgical navigation in image guided surgery. One retail carton is made up of 5 spheres per tray in a pouch. There are 12 tray-in-pouches for a total of 60 spheres.

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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Data 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.