microTargeting™ STar™ Drive Insertion Tube Set
FHC, INC. · Model 70-IT-AR-00217 · UDI-DI 00873263002179
10
510(k) clearances
351
Adverse events
2
Recalls
212
Facilities
Description
STar(TM) Drive Array Electrode Insertion Tube Set for use with stereotactic frames, non-sterile Contains: 6 - IT(AR16) Guide Tube (does not enter brain) 6 - IT(AR17) Insertion Tube with Stylet - 241.5mm length, 0.90mm od, 0.60mm id 1 - IT(AR3), DBS Lead Insertion Tube with Stylet - 239.85mm length, 1.83mm od, 1.60mm id 2 - Insertion Tube Extractors
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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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.