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Inspire

Inspire Medical Systems, Inc. · Model 900-023-001 · UDI-DI 10810098650066

HAO Prescription

510(k) clearances

351

Adverse events

Recalls

212

Facilities

Description

A nonpowered neurosurgical instrument is a hand instrument or an accessory to a hand instrument used during neurosurgical procedures to cut, hold, or manipulate tissue. It includes specialized chisels, osteotomes, curettes, dissectors, elevators, forceps, gouges, hooks, surgical knives, rasps, scissors, separators, spatulas, spoons, blades, blade holders, blade breakers, probes, etc.

Recalls

Date	Firm	Reason
2011-04-04	Zimmer Inc.	A rounded or partially rounded tip on the screwdriver may not provide the required locking torque to lock the closure top to the polyaxial screw. When the hex tip of the screwdrive
2010-07-02	Integra LifeSciences Corp	Certain NeuroBalloon Catheters have the potential to improperly inflate or deflate under certain conditions.

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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.