|
100747
|
Z-2721-2011
|
Terminated
|
DWJ
|
2011-05-02
|
Cincinnati Sub-Zero Products Inc
|
ECMO Heater Model 333W, Cardiopulmonary bypass temperature controllers.
This device is intended to provide temperature-controlled warm water flow to a blood heat exchanger in order to maintain a patient's blood temperature. It can be used during extracorporeal circulation procedures. It is intended to use with commercially available heat exchangers.
|
|
100340
|
Z-2700-2011
|
Terminated
|
LJS
|
2011-04-26
|
Vygon Corporation
|
LIFECATH S PICC with Microflash Introducer
Catheter, Percutaneous, Intravascular
Product Code 2296.214
Product Usage: Intravascular catheter
|
|
100643
|
Z-2703-2011
|
Terminated
|
MBI
|
2011-01-26
|
Linvatec Corp. dba ConMed Linvatec
|
"***LINVATEC SRS SHOULDER RESTORATION SYSTEM CrossFT 5.5mm CrossFT Suture Anchor with Two#2 (5 metric) Hi-Fi Sutures***SRS.Linvatec.com***ConMed Linvatec Biomaterials, Ltd. Hemiankatu 6-8L 33720 Tampere, FINLAND***STERILE EO***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA Made in USA***REF CFP-5502***"
The non absorbable suture anchor is intended to reattach soft tissue to bone in orthopedic surgical procedures.
|
|
100394
|
Z-2702-2011
|
Terminated
|
MUJ
|
2011-05-03
|
Varian Medical Systems, Inc. Oncology Systems
|
Eclipse Radiation Treatment Planning System, model H48;
Varian Medical Systems Inc..
|
|
100841
|
Z-2687-2011
|
Terminated
|
FMI
|
2010-11-05
|
Pyng Medical Corporation
|
The product is the "FASTx Sternal Intraosseous Device".
The expiration date for the recalled products is end of June, 2012.
The device is used to insert an infusion tube into the manubrium (upper portion of the sternum) of a patient. It is intended for intraosseous infusion as an alternative to intravenous access, to facilitate emergency resuscitation through the use of drugs and fluids. It is indicated for use in establishing a sternal intraosseous access route in adult and adolescent patients (12 years of age and older) requiring vascular administration of drugs or fluids to facilitate emergency resuscitation.
|
|
99553
|
Z-2713-2011
|
Terminated
|
LXH
|
2011-04-07
|
Biomet, Inc.
|
Comprehensive Shoulder Instruments Fracture Stem Inserter w/Version Control, REF 31-406901, Biomet Orthopedics Warsaw, IN, Instrument used to introduce the stem into the canal.
The instrument is used to insert the shoulder implant into the shoulder.
|
|
101484
|
Z-2770-2011
|
Terminated
|
DQO
|
2011-06-09
|
Vascular Solutions, Inc.
|
Langston Dual Lumen Catheters, REF 5515, 7F, Sterile EO, Rx ONLY, 1 x Catheter and 5 x Catheter, Vascular Solutions, Inc., 6464 Sycamore Court, Minneapolis, MN 55369.
Langston dual lumen catheters are indicated for delivery of contrast medium in angiographic studies and for simultaneous pressure measurement from two sites. This type of pressure measurement is useful in determining transvalvular, intravascular and intraventricular pressure gradients.
|
|
101124
|
Z-2832-2011
|
Terminated
|
JCT
|
2011-05-25
|
Boston Scientific Corporation
|
Boston Scientific, WALLSTENT" Endoprosthesis & WALLSTENT" RP Endoprosthesis, Self Expanding Stent, Stent Auto-expanisvel, Made in Ireland, Ballybrit Business Park, Galway, IRELAND, STERILE, EO.
Indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.
WALLSTENT" Endoprosthesis
Material Catalog # Description
H965402100 40210 12X20/8FR UNI PLUS HALO 100CM
H965402110 40211 12X40/8FR UNI PLUS HALO 100CM
H965402120 40212 12X60/8FR UNI PLUS HALO 100CM
H965402130 40213 12X90/8FR UNI PLUS HALO 100CM
H965403100 40310 14X20/9FR UNI PLUS HALO 100CM
H965403110 40311 14X40/9FR UNI PLUS 100CM
H965403120 40312 14X60/9FR UNI PLUS 100CM
H965403130 40313 14X90/9FR UNI PLUS 100CM
H965403300 40330 16X20/9FR UNI PLUS 100CM
H965403310 40331 16X40/9FR UNI PLUS 100CM
H965403320 40332 16X60/9FR UNI PLUS 100CM
H965403330 40333 16X90/9FR UNI PLUS 100CM
H965404110 40411 18X40/10FR UNI PLUS 100CM
H965404120 40412 18X60/10FR UNI PLUS 100CM
H965404130 40413 18X90/10FR UNI PLUS 100CM
H965404300 40430 20X40/10FR UNI PLUS 100CM
H965404310 40431 20X55/10FR UNI PLUS 100CM
H965404320 40432 20X80/10FR UNI PLUS 100CM
H965404500 40450 22X35/10FR UNI PLUS 100CM
H965404510 40451 22X45/10FR UNI PLUS 100CM
H965404520 40452 22X70/10FR UNI PLUS 100CM
H965405100 40510 24X35/11FR UNI PLUS 100CM
H965405110 40511 24X45/11FR UNI PLUS 100CM
H965405120 40512 24X70/11FR UNI PLUS 100CM
H965412000 41200 12X20/135CM 8FR BARE UNI + HALO 160CM
H965412010 41201 12X40/135CM 8FR BARE UNI + HALO 160CM
H965412020 41202 12X60/135CM 8FR BARE UNI + HALO 160CM
H965412030 41203 12X90/135CM 8FR BARE UNI + HALO 160CM
WALLSTENT" RP Endoprosthesis
Material Catalog # Description
M001711000 71-100 5x20x75/ 6F Unistep Plus
M001711010 71-101 5x20x135/ 6F Unistep Plus
M001711020 71-102 5x40x75/ 6F Unistep Plus
M001711030 71-103 5x40x135/ 6F Unistep Plus
M001711040 71-104 5x55x75/ 6F Unistep Plus
M001711050 71-105 5x55x135/ 6F Unistep Plus
M001711060 71-106 5x80x75, 6F Unistep Plus
M001711080 71-108 6x20x75/ 6F Unistep Plus
M001711090 71-109 6x20x135/ 6F Unistep Plus
M001711100 71-110 6x45x75/ 6F Unistep Plus
M001711110 71-111 6x45x135/ 6F Unistep Plus
M001711120 71-112 6x60x75/ 6F Unistep Plus
M001711130 71-113 6x60x135/ 6F Unistep Plus
M001711140 71-114 6x90x75/ 6F Unistep Plus
M001711150 71-115 6x90x135/ 6F Unistep Plus
M001711160 71-116 7x20x75/ 6F Unistep Plus
M001711160 71-116 7x20x75/ 6F Unistep Plus
M001711170 71-117 7x20x135/ 6F Unistep Plus
M001711180 71-118 7x40x75/ 6F Unistep Plus
M001711190 71-119 7x40x135/ 6F Unistep Plus
M001711200 71-120 7x60x75/ 6F Unistep Plus
M001711210 71-121 7x60x135/ 6F Unistep Plus
M001711220 71-122 7x90x75/ 6F Unistep Plus
M001711230 71-123 7x90x135/ 6F Unistep Plus
M001711240 71-124 8x20x75/ 6F Unistep Plus
M001711250 71-125 8x20x135/ 6F Unistep Plus
M001711260 71-126 8x40x75/ 6F Unistep Plus
M001711270 71-127 8x40x135/ 6F Unistep Plus
M001711280 71-128 8x60x75/ 6F Unistep Plus
M001711290 71-129 8x60x135/ 6F Unistep Plus
M001711300 71-130 8x80x75/ 6F Unistep Plus
M001711310 71-131 8x80x135/ 6F Unistep Plus
M001711320 71-132 10x20x75/ 6F Unistep Plus
M001711330 71-133 10x20x135/ 6F Unistep Plus
M001711340 71-134 10x42x75/ 7F Unistep Plus
M001711350 71-135 10x42x135/ 7F Unistep Plus
M001711360 71-136 10x68x75/ 7F Unistep Plus
M001711370 71-137 10x68x135/ 7F Unistep Plus
M001711380 71-138 10x94x75/ 7F Unistep Plus
M001711390 71-139 10x94x135/ 7F Unistep Plus
|
|
100493
|
Z-2838-2011
|
Terminated
|
NSP
|
2010-12-01
|
Biomet 3i, LLC
|
"***3i Incise Custom-Made Label. QP157 Approved 07/09/10*** 3i inc se Custom-made Dental Framework***Biomet 3i 4555 Riverside Drive Palm Beach Gardens, FL 33410 800-342-5454 www.biomet3i.com Please consult instructions for use and recommendation***For Dental Lab use ONLY Non-sterile/For single Use***"
Indicated for use in restorative procedure to affix the final prosthesis to the abutment. Coping and frameworks provide the base structure for final porcelain application as the final step of creating a restoration. The devices are intended to be used to create final restoration for dental reconstruction with either a prepared tooth or dental implant abutment.
|
|
101183
|
Z-2822-2011
|
Terminated
|
GAP
|
2011-06-03
|
Covidien LP
|
Syneture Surgilon 0 Blk 5X18 T-12/GS-21 D-TACH
non-absorbable braided nylon sutures
Material 8886196262
Surgilon is intended for use in general soft tissue approximation and/or ligation, including use in the cardiovascular, ophthalmic and neural tissue.
|
|
99943
|
Z-2446-2011
|
Terminated
|
KWA
|
2011-04-14
|
Biomet, Inc.
|
Ringloc + Acetabular Shell limited hole, 72 mm Size 28, porous coat, for uncemented use, sterile, REF 16-116072, Biomet Orthopedics, Warsaw, IN.
Intended Use: The Porous Plasma Spray (PPS) Ringloc ¿ Acetabular System is intended to replace the natural acetabulum damaged by disease, trauma or revision of previous arthroplasty. Indications For Use: 1 . Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed.
|
|
99899
|
Z-2442-2011
|
Terminated
|
KWA
|
2011-04-14
|
Biomet, Inc.
|
Ringloc + Acetabular Shell limited hole, 64 mm Size 26, porous coat, for uncemented use, sterile, REF 16-116064, Biomet Orthopedics, Warsaw, IN.
Intended Use: The Porous Plasma Spray (PPS) Ringloc ¿ Acetabular System is intended to replace the natural acetabulum damaged by disease, trauma or revision of previous arthroplasty. Indications For Use: 1 . Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed.
|
|
99889
|
Z-2434-2011
|
Terminated
|
KWA
|
2011-04-14
|
Biomet, Inc.
|
Ringloc + Acetabular Shell limited hole, 48 mm Size 22, porous coat, for uncemented use, sterile, REF 16-116048, Biomet Orthopedics, Warsaw, IN.
Intended Use: The Porous Plasma Spray (PPS) Ringloc ¿ Acetabular System is intended to replace the natural acetabulum damaged by disease, trauma or revision of previous arthroplasty. Indications For Use: 1 . Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed.
|
|
100180
|
Z-2553-2011
|
Terminated
|
HFS
|
2011-05-18
|
Medela Inc
|
Contact Nipple Shield (Sterile) - 24mm (Standard); Individually wrapped silicone contact nipple shields for immediate use for latch-on difficulties while breastfeeding the baby under professional care only; Manufactured for Medela, Inc., P.O. Box 660, McHenry, IL 60051-0660, Made in Switzerland; article #67203S
Individually wrapped for immediate use. For latch-on difficulties. Made of silicone. For use under professional care only while breastfeeding the baby.
|
|
99806
|
Z-2548-2011
|
Terminated
|
KWS
|
2011-04-22
|
Biomet, Inc.
|
Custom biomodular humeral tray 44 mm sterile, REF CP561686, Biomet Orthopedics, Warsaw, IN.
Biomet Comprehensive Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The Comprehensive Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.
|
|
99720
|
Z-2468-2011
|
Terminated
|
CBK
|
2009-10-27
|
Newport Medical Instruments Inc
|
Newport e360 Ventilator, Model Number: e360
The e360 Ventilator System is intended to provide continuous (endotracheal or tracheostomy [ET] tube) or non-continuous (mask) ventilatory support and monitoring for infant, pediatric, and adult patients requiring tidal volumes equal to or greater than 20 milliliters (mL). The device is for use by prescription only. The intended environments include hospital, hospital-type, and intra-hospital transport environments. Hospital use typically includes general care floors, operating rooms, special procedure areas, emergency rooms, and intensive and critical care areas within the hospital. Hospital-type use includes facilities such as or similar to surgicenters, sub-acute centers, and special nursing facilities outside of the hospital. Intra-hospital transport includes patient transport within the hospital or hospital-type facility.
|
|
99886
|
Z-2431-2011
|
Terminated
|
KWA
|
2011-04-14
|
Biomet, Inc.
|
Ringloc + Acetabular Shell limited hole finned 66 mm Size 27 porous coat, for uncemented use, sterile, REF 16-104166, Biomet Orthopedics, Warsaw, IN.
Intended Use: The Porous Plasma Spray (PPS) Ringloc ¿ Acetabular System is intended to replace the natural acetabulum damaged by disease, trauma or revision of previous arthroplasty. Indications For Use: 1 . Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed.
|
|
99855
|
Z-2423-2011
|
Terminated
|
KWA
|
2011-04-14
|
Biomet, Inc.
|
Ringloc + Acetabular Shell limited hole finned 50 mm Size 23 porous coat, for uncemented use, sterile, REF 16-104150, Biomet Orthopedics, Warsaw, IN.
Intended Use: The Porous Plasma Spray (PPS) Ringloc¿ Acetabular System is intended to replace the natural acetabulurn damaged by disease, trauma or revision of previous arthroplasty. Indications For Use: 1 . Non-inflamnmatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed.
|
|
100275
|
Z-2609-2011
|
Terminated
|
MRM
|
2011-05-02
|
ela Medical Llc
|
Paradym DR Model 8550 and Paradym VR Model 8250, Sterile EO, Manufactured in Italy by Sorin CRM S. r.l., Via Crescentino s.n., 13040 Saluggia(VC) Italy
PARADYM DR 8550 and PARADYM VR 8250 are indicated for use in patients who are at high risk of sudden cardiac death due to ventricular tachyarrhythmias and who have experienced one of the following situations: Survival of at least one episode of cardiac arrest (manifested by the loss of consciousness) due to ventricular tachyarrhythmia, recurrent, poorly tolerated sustained ventricular tachycardia (VT).
|
|
100487
|
Z-2570-2011
|
Terminated
|
NBW
|
2011-05-18
|
Roche Diagnostics Operations, Inc.
|
ACCU-CHECK PERFORMA STRIP NO. 05987288031, 100 BANDELETTES REACTIVES, ROCHE DIAGNOSTICS GMBH, WWW.ACCUCHEK.COM glucose monitoring test strips.
|