Style STE00059FG and Style STE00118FG

Neurological Devices

1

No

Nationwide.

Fitness Gear Inversion table (Style STE00059FG or Style STE00118FG), Distributed by ASLI, Wilmington, DE (on carton), Paradigm Health & Wellness, Inc. (in user manuals); The products are inversion tables, which allow the user to secure his or her ankles to the table and invert. The products were intended to be fitness equipment; i.e. consumer products.

EPWorks Software Versions prior to 6.0

Neurological Devices

2

No

US Nationwide Distribution

EPWorks software used in the Protektor 32 || Product Usage: || Uses electroencephalography (EEG), evoked potentials (EP), electromyography (EMG) and transcranial motor evoked potentials (TcMEP) stimulation techniques to provide healthcare professionals with information to help assess patients neurological status during surgery.

EPWorks Software Versions prior to 6.0

Neurological Devices

2

No

US Nationwide Distribution

EPWorks software used in the Xltek Protektor Stimulator || Product Usage: || Intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency.

Serial Numbers: H38309606702, H38309606704, H38309610105, H38309610104, H38309606701, H38309606703, H38309606705, H38309610101.

Neurological Devices

2

No

US Distribution to the states of: NC and CA., and Internationally to Switzerland.

16cm Minimally Invasive Attachment. For use with Motor Systems for cutting and shaping bones, including the spine and cranium. Model MIA16-G1

Serial numbers 100019, 100984, 100965, 100295, 100979, 100773, 100946, 100797, 100947, 100956, 100966, 100649, 100967, 100944, 100941, 100945, 100970, 100950, 100976, 100951, 100728, 100952, 100248, 100953, 100641, 100954, 100463, 100955, 100981, 100957, 100978, 100958, 100106, 100959, 100939, 100960, 100973, 100961, 100236, 100962, 100237, 100963, 100417, 100964. 100940, 100968, 100975, 100969, 100977, 100972, 100105, 100974, 100214, 100980, 100492, 100982, 100493, 100983, 100948, 100986, 100704, 100987, 100949, 100988, 100227, 100989, 100971, 100133, 100134, 100942.

Neurological Devices

2

No

Worldwide Distribution - US Nationwide in the states of AR, CO, FL, GA, IN, KS, KY, MA, MI, NC, NE, NJ, NY, OH, OK, PA, TX, WA, WY and the countries of Canada, Europe, and Asia.

Navigation System II-Cart, 7700-100-000 with Articulated Arm Camera, 7700-103-001 and Articulated Arm Camera, 7700-103-001U || Product Usage: || The Navigation System II-Cart is intended to be used as a platform for computer assisted surgery as part of the Stryker Navigation System. The intended use of the complete Stryker Navigation System is defined by the Stryker application modules.

Model/catalogue numbers: 19060 AIR ICT S&T; W/O G.C. NEUROLOGICA BODYTOM; 19065 MOBILE iCT AUTOMATIC IMAGE REG. CRANIAL. Potentially affected is the integration of the NeuroLogica BodyTom portable CT scanner for automatic registration with Brainlab Navigation devices (Cranial / ENT version 2.1 and Spine & Trauma 3D versions 2.0 and 2.1)

Neurological Devices

2

No

Distributed in the US and Australia.

BrainLAB Image Guided Surgery (IGS) System, Stereotaxic Instrument navigation software, Cranial ENT version 2.1, and Spine and Trauma 3D versions 2.0 and 2.1 An intraoperative image-guided localization system to enable minimally invasive surgery.

lot number 150223

Neurological Devices

2

No

US Distribution to the states of : CA, MO, LA and PA., and Internationally to Ireland.

Medtronic Passive Planar Blunt Probe Part Number 960-556, also included in Part Number Kits: 9732540, 9732622, 9733174, 9733935. As part of kits, the product is either packaged with other instruments or into a holding tray. The Passive Planar Blunt Probe is an optically tracked, reusable instrument used in navigated surgery and is included with Medtronic cranial instrument kits. It is designed for use in patient registration and palpating brain tissue during surgical procedures.

Correction includes all lots of products distributed between January 2007 and March 2015.  P/N: 9734240,Nav 6.5mm Tap (Cannulated),9734239, Nav 5.5mm Tap (Cannulated), 9734238,Nav 4.5mm Tap (Cannulated), 9734302,6.5mm Tap (Cannulated),9734300,5.5mm Tap (Cannulated),9734298,4.5mm Tap (Cannulated),9734303,7.5mm Tap (Cannulated),9734301,6.0mm Tap (Cannulated),9734299,5.0mm Tap (Cannulated),9734304,8.5mm Tap (Cannulated),9730944,4.5 mm Cannulated Tap,9730945,5.5 mm Cannulated Tap,9730946,6.5 mm Cannulated Tap,9733182,4.0 mm Cannulated Tap, 1.86P,9733183,4.5 mm Cannulated Tap,9733184,4 mm Cannulated Tap, 1.5P, UCSS,960-347,7.5 Old Round APT (Cannulated Tap-Tip only),960-345,6.5 Old Round APT (Cannulated Tap-Tip only),960-344,5.5 Old Round APT (Cannulated Tap-Tip only) The above referenced cannulated taps are included in the kits and,9731921,KIT 9731921 INSTRUMENT SPINE BASIC,9735101,INST KIT 9735101 TAP ASM 4.5 G5, 9735102,INST KIT 9735102 TAP ASM 5.5 G5,9735103,INST KIT 9735103 TAP ASM 6.5 G5,9735107,INST KIT 9735107 TAP ASM 5.0 G5,9735108,INST KIT 9735108 TAP ASM 6.0 G5,9735109,INST KIT 9735109 TAP ASM 7.5 G5,9735149,INST KIT 9735149 CANNULATED 6.5MM TAP,9735150,INST KIT 9735150 CANNULATED 5.5MM TAP,9735151,INST KIT 9735151 CANNULATED 4.5MM TAP,9735168,INST KIT 9735168 4MM TAP 1.86P,9735169,INST KIT 9735169 4.5MM CANN TAP,9735170,INST KIT 9735170 4MM TAP 1.5P,9734490,INST SET 9734490 LEGACY,9734491,INST SET 9734491 SOLERA STD,9734492,INST SET 9734492 SOLERA DEF UPGRADE,9735469,TAPS 9735469 CD HORIZON SOLERA,9734631,TD SET 9734631 LEGACY STD TAPS/DRIVERS,9734632,TD SET 9734632 SOLERA STD TAPS/DRIVERS,9733370,VERTEX MAX SET, 9733370, NAVIGATED,9734838,KIT 9734838 SOLERA 8.5 CANNULATED TAP,

Neurological Devices

2

No

Worldwide Distribution.

Medtronic Navigated Cannulated Taps || Individual cannulated taps are packaged in a clear plastic tube with protective plastic end caps. Kit/sets contain various devices including the taps. The kit/set configuration varies dependent on the part number. The devices are assembled and packaged into a shipping carton or into a holding tray which is then placed into a shipping carton. || Designed for use in spine surgery to assist in the tapping procedure and the placement of screws during the surgery.

305000291459, 305000299228, 305000300396, 305000301413, 305000312261, 305000315716, 30500X294240, 30500X304371, 30500X309674, 30500X318076, 3050RX285879, 3050RY297365, 305E00318970, 305E0X320986

Neurological Devices

2

No

Worldwide Distribution - US (Nationwide) and Internationally to ARGENTINA, BRAZIL, BULGARIA, CANADA, COLUMBIA, COSTA RICA, FRANCE, GERMANY, ITALY, MEXICO, GERMANY, ITALY, MEXICO, PANAMA, SOUTH AFRICA, SPAIN, SWITZERLAND, UNITED ARAB EMIRATES, AND UNITED KINGDOM

Integra Camino Intracranial Pressure Monitoring Catheter with Licox IMC Bolt Fitting, Catalog No. 110-4L || The Camino Intracranial Pressure Monitoring Catheter is a sterile transducer-tipped pressure monitoring catheter with accessory items to be used as a diagnostic tool for rapidly determining and continuously monitoring intracranial pressure. The Camino catheter has a miniature transducer at the distal tip. This design eliminates the need for a fluid-filled system to carry pressure waves to an external transducer and thus, the problems inherent in such fluid-filled systems are eliminated. The Camino catheter is packaged with a zero adjustment tool which allows for the adjustment of the transducer during catheter preparation, and the LICOX Bolt Adapter Fitting. The Camino Intracranial Pressure Monitoring Catheter with Licox IMC Bolt fitting, Model 110-4L is indicated for use by a qualified Neurosurgeon when direct measurement of intracranial pressure in the parenchyma is clinically important. It is intended to be used only through a Licox Brain Oxygen Monitoring System Bolt.

1) Catalog Number: 41773 (90 pack) Lot # C102061501

Neurological Devices

2

No

Worldwide - US Nationwide Distribution and the countries of Australia and Canada.

NDI Disposable Reflective Marker Spheres for Brainlab IGS (Image Guided Surgery) system. || Product Usage: || Disposable reflective marker spheres are attached to reference arrays and instruments, thus enabling the infrared tracking systems to detect the position of the patient and instruments in the surgical field.

OEM Catalog number A1072.

Neurological Devices

2

No

Distributed in DC and the states of CO, CA, FL, TX, and AR.

Medical Device Exchange - Mayfield Disposable Skull Pin; || Pouch, Tyvek/Mylar, Sterile, Single Use Only; || OEM Catalog number A1072; || EXP (repackager), Integra (OEM) || Holder, head, neurosurgical (skull clamp)

OEM Catalog number 5820-10-120.

Neurological Devices

2

No

Distributed in DC and the states of CO, CA, FL, TX, and AR.

Medical Device Exchange Round Fluted Bur Soft Touch; 2.0mm; || Pouch, Tyvek/Mylar, Sterile, Single Use Only; || OEM Catalog number 5820-10-120; || EXP (repackager), Stryker (OEM) || Drills, burrs, trephines & accessories || (simple, powered)

OEM Catalog number 5820-10-130.

Neurological Devices

2

No

Distributed in DC and the states of CO, CA, FL, TX, and AR.

Medical Device Exchange Round Diamond Bur Extra Coarse; 3.0mm; || Pouch, Tyvek/Mylar, Sterile, Single Use Only; || OEM Catalog number 5820-10-130; || EXP (repackager), Stryker (OEM) || Drills, burrs, trephines & accessories || (simple, powered)

OEM Catalog number 5820-10-160.

Neurological Devices

2

No

Distributed in DC and the states of CO, CA, FL, TX, and AR.

Medical Device Exchange 6.0mm Round Fluted Bur Soft Touch; || Pouch, Tyvek/Mylar, Sterile, Single Use Only; || OEM Catalog number 5820-10-160; || EXP (repackager), Stryker (OEM) || Drills, burrs, trephines & accessories || (simple, powered)

OEM Catalog number 5820-10-240.

Neurological Devices

2

No

Distributed in DC and the states of CO, CA, FL, TX, and AR.

Medical Device Exchange Round Fluted Bur Aggressive; 4.0mm; || Pouch, Tyvek/Mylar, Sterile, Single Use Only; || OEM Catalog number 5820-10-240; || EXP (repackager), Stryker (OEM) || Drills, burrs, trephines & accessories || (simple, powered)

Catalog numbers:STT0412-¿10 and STT0412-¿5;  Lot numbers : 1504021-¿01 and 1505008.

Neurological Devices

2

No

US Nationwide Distribution in the states of TX, NY, MD, CO and CA.

iovera 155 Smart Tip; || Catalog numbers:STT0412-10 and STT0412-5 (10 and 5 count respectively) || iovera Smart Tips are individually packaged in Tyvek PET pouches, which are || then packaged into 5 or 10 pack boxes and shipper boxes. || Product Usage: Cyrogenic Surgical Device The myoscience iovera device is used to destroy tissue during surgical procedures by applying freezing cold. It can also be used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain. The iovera device is not indicated for treatment of central nervous system tissue

Code:9001146  Lots: 141015719 exp. 10/31/15 140914967 exp. 10/31/15 150116564 exp. 2/28/16

Neurological Devices

1

No

Distributed Only in Puerto Rico.

NEURO PACK 3/CS || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. || .

Code:9001300 Lots: 141015765 exp. 11/30/15 150116761 exp. 11/30/15 150418292 exp. 5/31/16 150518636 exp. 5/31/16

Neurological Devices

1

No

Distributed Only in Puerto Rico.

NEURO SPINE PACK 3/CS || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. || .

LOT No: 066503515, 066504315, 066506515

Neurological Devices

2

No

Worldwide Distribution - US (nationwide) and Canada.

Medtronic Passive Biopsy Needle Kit, Part Number 9733068 - Passive Biopsy Needle Kit. || The image guided Passive Biopsy Needle is an accessory instrument with the StealthStation System. The Biopsy Needle is intended to be used for stereotaxy biopsy of brain tissue.

LOT No: 0007525461. 0007599312

Neurological Devices

2

No

Worldwide Distribution - US (nationwide) and Canada.

Medtronic Passive Biopsy Needle Kit, Part Number 9731754 - Passive Biopsy Fee Per Use (FPU) Kit. || The image guided Passive Biopsy Needle is an accessory instrument with the StealthStation System. The Biopsy Needle is intended to be used for stereotaxy biopsy of brain tissue.

Code:9002256 Lots: 141015762 exp. 11/30/15 141216323 exp. 12/31/15 141216323 exp. 12/31/15 150116792 exp. 3/31/16 150518691 exp. 5/31/16 150317817 exp. 5/31/16

Neurological Devices

1

No

Distributed Only in Puerto Rico.

NEURO PACK 2/CS || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. || .

models: I-Portal¿ NOTC-O I-Portal¿ NOTC-C,   with S/N 890739 S/N 900140 S/N 900133 S/N 900114 S/N 900172 S/N 900136 S/N 900162 S/N 900134 S/N 900137 S/N 900147 S/N 890739 S/N 900140 S/N 900169 S/N 890738 S/N 900133 S/N 900118 S/N 900127 S/N 900138 S/N 900163 S/N 890742 S/N 890773 S/N 900155 S/N 900150 S/N 900158 S/N 900125 S/N 900123 S/N 900108 S/N 900114 S/N 900160 S/N 900168 S/N 900102 S/N 900130 S/N 900131 S/N 900128 S/N 900144 S/N 890741 S/N 890726 S/N 890736 S/N 900145 S/N 900111 S/N 900119

Neurological Devices

2

No

Worldwide Distribution - US (nationwide)

Neuro Kinetics, Inc. (NKI) I-Portal¿ NOTC system with the OVAR research test; a rotary chair system used in vestibular and neuro-otologic diagnostic testing. This device provides no diagnoses nor does it provide diagnostic recommendations.The OVAR test has not yet been cleared by the FDA, and until then can only be used as an investigational device.

Cat. No. UCHRAP; Serial No.s 900, 901, 902, 904, 905, 906

Neurological Devices

2

No

Worldwide Distribution - US Distribution to the states of : NJ, TX and WY., and to the countries of : Algeria, Germany and India.

Universal Compact Head Ring Adapter Plate (UCHRAP), a component of the Universal Compact Head Ring Adapter, UCHRA. The UCHRA is a component of the Integra¿ CRW¿ Precision Arc Stereotactic System.

Serial Numbers A1221, A1226 (Ship Date 07/2015);   Serial Numbers A1061, A1250, A1251 (Ship Date 05/2015);   Serial Number A1246 (Ship Date 04/2015);   Serial Numbers A1245, A1244, A1042, A1243 (Ship Date 02/2015);   Serial Number A1225 (Ship Date 01/2015);   Serial Numbers A1241, A1242 (Ship Date 12/2014);   Serial Number A1036 (Ship Date 11/2014);   Serial Numbers A1229, A1247, A1224 (Ship Date 10/2014);   Serial Numbers A1239, A1234, A1236, A1237, A1238, A1233, A1228, A1231, A1232, A1235 (Ship Date 09/2014);   Serial Number A1227 (Ship Date 08/2014);   Serial Number A1223 (Ship Date 07/2014);   Serial Numbers A1218, A1220 (Ship Date 06/2014);   Serial Numbers A1217, A1216, A1248 (Ship Date 04/2014);   Serial Numbers A1214, A1064 (Ship Date 03/2014);   Serial Numbers A1087, A1213 (Ship Date 01/2014);   Serial Numbers A1201, A1203, A1204, A1205, A1206, A1209, A1210, A1211, A1212, A1094, A1200, A1207, A1091, A1092, A1093, A1201 (Ship Date 12/2013;   Serial Numbers A1075, A1076, A1077, A1078, A1079, A1080, A1081, A1082, A1083, A1070, A1072, A1073, A1084, A1086, A1087, A1088, A1089, A1090, A1085 (Ship Date 11/2013);   Serial Numbers A1022, A1044 (Ship Date 10/2013);   Serial Number A1059 (Ship Date 09/2013);   Serial Numbers A1021, A1060, A1062, A1063, A1065, A1066, A1067, A1069 (Ship Date 08/2013);   Serial Numbers A1037, A1005, A1015, A1024, A1230, A1050, A1051, A1052, A1053, A1054, A1055, A1058, A1016, A1019, A1064, A1249 (Ship Date 07/2013);   Serial Numbers A1006, A1020, A1004, A1023, A1021 (Ship Date 05/2013);   Serial Numbers A1025, A1046, A1032 (Ship Date 04/2013);   Serial Numbers A1038, A1049, A1029, A1026, A1035, A1039, A1036, A1031, A1030, A1028, A1027, A1034 (Ship Date 03/2013);   Serial Number P11 (Ship Date 02/2013);   Serial Number P-7 (Ship Date 11/2012);   Serial Numbers A1013, P-8 (Ship Date 09/2012);   Serial Numbers A1043, P-6, A1041, P-9 (Ship Date 07/2012);

Neurological Devices

2

No

Nationwide Distribution.

The "Pacifier Activated Lullaby" (PAL) System composed of three major components: 1) the PAL Player Module (aka Player Unit), 2) the PAL Pacifier Sensor, and 3) power supply. The system is designed to encourage and reinforce effective non-nutritive sucking of premature infants.

00260001  00260002 00260006 00260007 00260005 00260003 00260004 00260012

Neurological Devices

2

No

US: FL, WI, IL, LA, WA.

Synaptive Medical BrightMatter Navigator System (Guide System). Part number SYN-0026. The Guide system is comprised of a cart labelled SYN-0024 and a cart labelled SYN-0025, Operator Cart. A planning and intraoperative guidance system to enable open and percutaneous computer assisted surgery. The system is indicated for medical conditions requiring neurosurgical cranial procedures. It can be used for intra-operative guidance where a reference to a rigid anatomical structure can be identified.