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microTargeting™ Electrode and Insertion Tube Kit

FHC, INC. · Model KTF1002-00134 · UDI-DI 10873263001346

HAO GZL HAW Prescription

510(k) clearances

351

Adverse events

Recalls

212

Facilities

Description

microTargeting STar Array Electrode and Insertion Tube Kit, 5x, for use with Stereotactic Frame and STar Drive. Contains: IT(AR16): Insertion Tube. IT(AR17): Insertion Tube w/ Stylet. MTDWLN(AR)(AR2): microTargeting Electrode. 66-CN-ET: Insertion Tube Extractor. Individual Specifications: IT(AR16) - 135mm tube length, 1.981mm OD, 0.96mm ID. IT(AR17) - 243.5mm tube length, 0.902mm OD, 0.597mm ID, 264mm stylet length (includes collar). MTDWLN(AR)(AR2) - 276.5mm electrode length, 10mm differential, 261.5mm protective tube length, 0.55mm OD. DZAP(L) 1 Meg

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.