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Preguntas frecuentes
Créditos
Manufacturers
Surgical Instrument Service And Savings, Inc.
Dirección del fabricante
Surgical Instrument Service And Savings, Inc., 2747 Sw 6th St, Redmond OR 97756-7109
Empresa matriz del fabricante (2017)
Medline Industries Inc.
Source
USFDA
22 Events
Retiro De Equipo (Recall) de Device Recall Harmonic ACE ErgonomicallyEnhanced Curved Shear, Pistol Grip, Hand Controlled,
Retiro De Equipo (Recall) de Device Recall ENDOPATH Resposable Bladeless Trocar, NonHandled, w/Housing,
Retiro De Equipo (Recall) de Device Recall Turbosonics MiniFlared ABS Tip
Retiro De Equipo (Recall) de Device Recall CLEARTRAC COMPLETE, Threaded Cannula with Obturator
Retiro De Equipo (Recall) de Device Recall ACCUPASS; ENDOSCRUB; Spectrum
Retiro De Equipo (Recall) de Device Recall Relieva Flex
Retiro De Equipo (Recall) de Device Recall SCD Express; VasoForce; Benaflow
Retiro De Equipo (Recall) de Device Recall TPS Micro Reciprocating Small Tear Cross Cut Rasp
Retiro De Equipo (Recall) de Device Recall IDEAL 30 Suture Grasper (Green) 30 Degree
Retiro De Equipo (Recall) de Device Recall Midas Rex
Retiro De Equipo (Recall) de Device Recall Large Tear Cross Cut Rasp
Retiro De Equipo (Recall) de Device Recall Abrader; AcromioBlaster; CoolCut; Dyonics; Elite; Formula; Gator; Great White; Incisor; RazorCut; Sy
Retiro De Equipo (Recall) de Device Recall Barron Radial Vacuum Trephine
Retiro De Equipo (Recall) de Device Recall Acorn Bur,
Retiro De Equipo (Recall) de Device Recall Hall MicroChoice
Retiro De Equipo (Recall) de Device Recall ReNew II Endocut Scissor Tip,
Retiro De Equipo (Recall) de Device Recall CAPSure; Coblator; CoVAC; ArthroWand; Microblastor; Saber; Saphyre; SERFAS; TriStar; VARP; Vulcan.
Retiro De Equipo (Recall) de Device Recall Scorpion and SureFire Scorpion
Retiro De Equipo (Recall) de Device Recall GII QuickAnchor Plus
Retiro De Equipo (Recall) de Device Recall ENDOPATH; Ligaclip MCA; Proximate Plus; and TX Stapler
Retiro De Equipo (Recall) de Device Recall ConMed Linvatec Spectrum II and Arthrex SutureLasso
Retiro De Equipo (Recall) de Device Recall Instratek Carpal Tunnel Release Blades
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22 dispositivos en la base de datos
Device Recall Harmonic ACE ErgonomicallyEnhanced Curved Shear, Pistol Grip, Hand Controlled,
Modelo / Serial
122295, 122308, 122762.
Clasificación del producto
General and Plastic Surgery Devices
Clase de dispositivo
Unclassified
¿Implante?
No
Distribución
Nationwide Distribution.
Descripción del producto
Harmonic ACE Ergonomically-Enhanced Curved Shear, Pistol Grip, Hand Controlled, (White) 5.0mm x 36cm Ref. ACE36E Lot 122295, 122308, 122762 || Unclassified
Device Recall ENDOPATH Resposable Bladeless Trocar, NonHandled, w/Housing,
Modelo / Serial
122338, 122347, 122454, 122592, 123372, 122490, 122490, 123254, 122609, 122429, 123215, 122647, 122300.
Clasificación del producto
Gastroenterology-Urology Devices
Clase de dispositivo
2
¿Implante?
No
Distribución
Nationwide Distribution.
Descripción del producto
- ENDOPATH Resposable Bladeless Trocar, Non-Handled, w/Housing, 100mm, (Green) 10/11mm Ref. 511NA Lot 123215, 122647 || - ENDOPATH Resposable Bladeless Trocar, Non-Handled, w/Housing, 100mm, (Orange) 5.0mm Ref. 35LNA Lot 123215, 122647 || - ENDOPATH Resposable Trocar w/Dilating Tip Obturator & Housing, 100mm, (Orange) 5mm Ref. 35LDA Lot 122647 || - ENDOPATH Resposable Trocar, Dilating Tip w/Housing, 100mm, (Purple) 10/12mm Ref. 512DA Lot 123215 || - ENDOPATH Sleeve Housing (Orange) 5mm Ref. 355HR Lot 123215, 122647 || Endoscope and accessories || - ENDOPATH Trocar, Disposable Sleeve Housing, (Green) 10/11mm Ref. 511HR Lot 122647 || - ENDOPATH Blunt Tip Obturator & Housing, w/Olive Plug, 100mm, (Purple) 10/12mm Ref. 512BA Lot 122647 || - ENDOPATH Resposable Trocar w/ Dilating Tip Obturator & Housing, 100mm, (Green) 10/11mm Ref. 511DA Lot 122454, 122647 || - ENDOPATH, Bladeless Trocar with Stability Sleeve, Non-handled 10/12mm Ref. 512NT Lot 123254 || - ENDOPATH Xcel Bladeless Trocar, Handled, w/Stability Sleeve, (Teal) 11mm x 100mm Ref. 811LTH Lot 122300 || - ENDOPATH Xcel Bladeless Trocar, w/Stability Sleeve 12mm x 150mm Ref. B12XT Lot 122300 || - ENDOPATH Xcel Bladeless Trocar, w/Stability Sleeve 5.0mm x 150mm Ref. B5XT Lot 122429 || - ENDOPATH Xcel Bladeless Trocar, w/Stability Sleeve, (Teal) 11mm x 100mm Ref. B11LT Lot 122454, 123254, 122429 || - ENDOPATH Xcel Bladeless Trocar, w/Stability Sleeve, 100mm Length 5.0mm Ref. B5LT Lot 122347, 122454, 122592, 122490, 123254, 122429, 122300 || - ENDOPATH Xcel Bladeless Trocar, w/Stability Sleeve, 75mm Length, (Teal) 5.0mm Ref. B5ST Lot 123254 || - ENDOPATH Xcel Blunt Tip Trocar, w/Smooth Sleeve & Adjustable Plug, (Purple) 12mm x 100mm Ref. H12LP Lot 122338, 122372, 123254, 123215 || - ENDOPATH Xcel Dilating Tip Trocar, w/Stability Sleeve, (Gold) 11mm x 100mm Ref. D11LT Lot 122454 || - ENDOPATH Xcel Dilating Tip Trocar, w/Stability Sleeve, (Gold) 12mm x 100mm Ref. D12LT Lot 122454 || - ENDOPATH Xcel Dilating Tip Trocar, w/Stability Sleeve, (Gold) 5.0mm x 100mm Ref. D5LT Lot 122338, 122454, 122490, 122429 || - ENDOPATH Xcel Integrated Stability Trocar Sleeve 11mm x 100mm Ref. CB11LT Lot 122429 || - ENDOPATH Xcel Integrated Stability Trocar Sleeve 12mm x 100mm Ref. CB12LT Lot 122490 || - ENDOPATH Xcel Integrated Stability Trocar Sleeve 5.0mm x 100mm Ref. CB5LT Lot 122490, 122429, 122300 || - Kii Optical Access System Threaded (Blue) 5mm x 100mm Ref. C0Q04 Lot 122609
Device Recall Turbosonics MiniFlared ABS Tip
Modelo / Serial
122590, 123372, 123215, 122309.
Clasificación del producto
Ophthalmic Devices
Clase de dispositivo
2
¿Implante?
No
Distribución
Nationwide Distribution.
Descripción del producto
- Turbosonics Mini-Flared ABS Tip, 45 Degree OZil 12 Degree, (Purplish/ Pink) 0.9mm Ref. 8065751177 Lot 123215 || - TurboSonics¿ Mini-Flared ABS¿ Tip, 20 Degree Tip Angle, 45¿ Kelman, (Purplish Pink/Silver) 0.9mm Ref. 8065750853 Lot 122590, 123372 || - TurboSonics¿ Tapered ABS¿ MicroTip" 30¿ Kelman, (Purple/Silver) 0.9mm Ref. 8065750263 Lot 122309 || Series 20000" Legacy¿ TurboSonics¿ Flared ABS MicroTip, 30 Degree, Kelman, (Pink) 0.9mm Ref. 8065740839 Lot. 122309 || Phacofragmentation system.
Device Recall CLEARTRAC COMPLETE, Threaded Cannula with Obturator
Modelo / Serial
122590, 123263, 123190, 122504, 122493, 122594, 123043, 122631, 122609, 122465, 122440, 122588, 122518, 122279, 122278, 122434, 122665.
Clasificación del producto
Orthopedic Devices
Clase de dispositivo
1
¿Implante?
No
Distribución
Nationwide Distribution.
Descripción del producto
- CLEAR-TRAC COMPLETE, Threaded Cannula with Obturator, (Grey) 7.0mm x 72mm Ref. 72200905 Lot 122631, 122609 || - CLEAR-TRAC Flexible Cannula System Threaded, w/Obturator, (Lime Green) 8.0mm x 72mm Ref. 72200425 Lot 122631 || - CLEAR-TRAC Flexible Cannula, Threaded, w/Obturator, (Orange) 6.5mm x 72mm Ref. 72200427 Lot 122465 || - Crystal Cannula w/Obturator (Orange) 5.75mm I.D. X 7cm Ref. AR-6460 Lot 122594, 122518 || - Crystal Cannula, Partially Threaded, Distal End, w/Obturator, (Orange) 5.75mm I.D. x 7cm Ref. AR-6564 Lot 122493 || - Dry-Doc Cannula System w/ Obturator (Translucent Green) 5.0mm x 85mm Ref. C7350 Lot 123263 || - Dry-Doc Cannula w/ Obturator (Translucent Blue) 7.0mm x 85mm Ref. C7360 Lot 123263, 122594 || - Instrument Cannula w/Obturator w/"No Squirt Cap", (Purple) 7.0mm I.D. X 7cm Ref. AR-6550 Lot 122590 || - Partially Threaded Cannula and Obturator, w/o "No Squirt Cap", (Purple) 7.0mm I.D. x 7cm Ref. AR-6567* Lot 123043, 122278 || - PassPort Button Cannula" (Blue) 8mm ID x 4cm Ref. AR-6592-08-40 Lot 122594 || - Smooth Clear Cannula w/Obturator (Orange) 5.5mm x 75mm Ref. 214106 Lot 122465 || - Threaded Clear Cannula w/Obturator (Orange) 5.5mm x 75mm Ref. 214108 Lot 122665 || - Threaded Clear Cannula w/Obturator (Yellow) 8.5mm x 75mm Ref. 214120 Lot 122440, 122588 || - Threaded Clear Cannula w/Obturator, (Purple) 7.0mm x 75mm Ref. 214116 Lot 122465 || - Tibial Tunnel Cannula, Accomodates 9-12 mm Tunnel Diameters, (Blue) Ref. AR-1802D Lot 122594, 122279 || - Twist-In Cannula w/Obturator w/"No Squirt Cap", (Gold) 8.25mm I.D. X 7cm Ref. AR-6530 Lot 122590, 123190, 122665 || - Twist-In Cannula w/Obturator, w/ "No-Squirt" Cap, (Green) 6.0mm I.D. x 7cm Ref. AR-6535 Lot 122590, 122665 || - Twist-In Cannula w/Obturator, w/"No Squirt Cap", (Purple) 7.0mm I.D. x 7cm Ref. AR-6570 Lot 123190 || - Twist-In Cannula w/Obturator, w/o "No Squirt Cap", (Purple) 7.0mm I.D. x 7cm Ref. AR-6570* Lot 123043 || - Twist-In Cannula w/Obturator, w/o No Squirt Cap, (Gold) 8.25mm I.D. x 7cm Ref. AR-6530* Lot 122504, 122493, 123043 || - Universal Cannula w/Obturator, 76mm long (Green) 7.0mm Ref. 012421 Lot 123043 || - Universal Cannula, w/Obturator and Trocar (Blue) 5.0mm I.D. x 76mm Ref. 012405 Lot 123043, 122434 || Arthoscope
Device Recall ACCUPASS; ENDOSCRUB; Spectrum
Modelo / Serial
123263, 122504, 122406, 122592, 122482, 123043, 122289, 122518, 122511.
Clasificación del producto
Orthopedic Devices
Clase de dispositivo
1
¿Implante?
No
Distribución
Nationwide Distribution.
Descripción del producto
- ACCU-PASS Suture Shuttle, 70 Degree, Upbend, (Orange) Ref. 72200419 Lot 122504 || - Carpal Tunnel Release Blade Assembly, (White) Ref. 81010 Lot 123263, 122406, 122482, 123043, 122518, 122511 || - ENDO-SCRUB 2, (1) Sheath, 0 Degree, For K. Storz, Medtronic Sharpsite AC, (Green) 4.0mm Ref. 19-12000 Lot 122289 || - Spectrum II Disposable Suture Hook 45 degree, Right (RED) Ref. C6380 Lot 122592 || Orthopedic manual surgical instrument.
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