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Crédits
Manufacturers
Surgical Instrument Service And Savings, Inc.
Adresse du fabricant
Surgical Instrument Service And Savings, Inc., 2747 Sw 6th St, Redmond OR 97756-7109
Société-mère du fabricant (2017)
Medline Industries Inc.
Source
USFDA
22 Events
Rappel de Device Recall Harmonic ACE ErgonomicallyEnhanced Curved Shear, Pistol Grip, Hand Controlled,
Rappel de Device Recall ENDOPATH Resposable Bladeless Trocar, NonHandled, w/Housing,
Rappel de Device Recall Turbosonics MiniFlared ABS Tip
Rappel de Device Recall CLEARTRAC COMPLETE, Threaded Cannula with Obturator
Rappel de Device Recall ACCUPASS; ENDOSCRUB; Spectrum
Rappel de Device Recall Relieva Flex
Rappel de Device Recall SCD Express; VasoForce; Benaflow
Rappel de Device Recall TPS Micro Reciprocating Small Tear Cross Cut Rasp
Rappel de Device Recall IDEAL 30 Suture Grasper (Green) 30 Degree
Rappel de Device Recall Midas Rex
Rappel de Device Recall Large Tear Cross Cut Rasp
Rappel de Device Recall Abrader; AcromioBlaster; CoolCut; Dyonics; Elite; Formula; Gator; Great White; Incisor; RazorCut; Sy
Rappel de Device Recall Barron Radial Vacuum Trephine
Rappel de Device Recall Acorn Bur,
Rappel de Device Recall Hall MicroChoice
Rappel de Device Recall ReNew II Endocut Scissor Tip,
Rappel de Device Recall CAPSure; Coblator; CoVAC; ArthroWand; Microblastor; Saber; Saphyre; SERFAS; TriStar; VARP; Vulcan.
Rappel de Device Recall Scorpion and SureFire Scorpion
Rappel de Device Recall GII QuickAnchor Plus
Rappel de Device Recall ENDOPATH; Ligaclip MCA; Proximate Plus; and TX Stapler
Rappel de Device Recall ConMed Linvatec Spectrum II and Arthrex SutureLasso
Rappel de Device Recall Instratek Carpal Tunnel Release Blades
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22 dispositifs dans la base de données
Device Recall Harmonic ACE ErgonomicallyEnhanced Curved Shear, Pistol Grip, Hand Controlled,
Modèle / numéro de série
122295, 122308, 122762.
Classification du dispositif
General and Plastic Surgery Devices
Classe de dispositif
Unclassified
Dispositif implanté ?
No
Distribution
Nationwide Distribution.
Description du dispositif
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,
Modèle / numéro de série
122338, 122347, 122454, 122592, 123372, 122490, 122490, 123254, 122609, 122429, 123215, 122647, 122300.
Classification du dispositif
Gastroenterology-Urology Devices
Classe de dispositif
2
Dispositif implanté ?
No
Distribution
Nationwide Distribution.
Description du dispositif
- 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
Modèle / numéro de série
122590, 123372, 123215, 122309.
Classification du dispositif
Ophthalmic Devices
Classe de dispositif
2
Dispositif implanté ?
No
Distribution
Nationwide Distribution.
Description du dispositif
- 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
Modèle / numéro de série
122590, 123263, 123190, 122504, 122493, 122594, 123043, 122631, 122609, 122465, 122440, 122588, 122518, 122279, 122278, 122434, 122665.
Classification du dispositif
Orthopedic Devices
Classe de dispositif
1
Dispositif implanté ?
No
Distribution
Nationwide Distribution.
Description du dispositif
- 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
Modèle / numéro de série
123263, 122504, 122406, 122592, 122482, 123043, 122289, 122518, 122511.
Classification du dispositif
Orthopedic Devices
Classe de dispositif
1
Dispositif implanté ?
No
Distribution
Nationwide Distribution.
Description du dispositif
- 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.
17 en plus
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